Data / Medical devices / China / Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC
Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC: FDA-registered device maker in Shanghai, China, 8 510(k) clearances
Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC is registered with the FDA (registration 3012027770) in Shanghai, China. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 17, 2024. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012027770
- Address
- Building A1, #718 Lingshi Road JingAn District, Shanghai, China, 200072
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Specification developer
- First device listed
- November 12, 2003
- Registered through
- 2026
- Brand names listed
- 12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951, 2-CH Patch, 40494E, Limb Clamp Electrode, 989803129231, Alligator Clips, AMMI, 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length, 989803151641, 12-Lead Complete Lead Set (IEC), Standard Length, 989803151651, 12-Lead Complete Lead Set (AAMI), Long, 989803151661, 12-Lead Complete Lead Set (IEC), Long and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Specification developer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Specification developer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Specification developer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Specification developer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 17, 2024 | K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | DPS | Substantially Equivalent | Philips Medizin Systeme Böblingen GmbH | accessdata.fda.gov |
| December 2, 2022 | K221141 | PageWriter TC35 Cardiograph | DPS | Substantially Equivalent | Medizin Systeme Boblingen GmbH | accessdata.fda.gov |
| July 18, 2012 | K121638 | ST80I STRESS TEST SYSTEM | DQK | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| June 29, 2012 | K120855 | INTELLISPACE ECG | DQK | Substantially Equivalent | Philips Health Care | accessdata.fda.gov |
| April 3, 2012 | K113144 | PAGEWRITER TC 20, 30, 50, 70 | DPS | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| May 9, 2008 | K080999 | PAGEWRITER CARDIOGRAPH | DPS | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| July 24, 2007 | K071733 | DL900 SERIES HOLTER RECORDER | MWJ | Substantially Equivalent | Braemar, Inc. | accessdata.fda.gov |
| September 28, 2001 | K010949 | 2010 PLUS HOLTER FOR WINDOWS | MLO | Substantially Equivalent | Agilent Technologies | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
- All makers of Electrode, Electrocardiograph
- All makers of Cable, Electrode
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
Updated December 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.