Data / Medical devices / United States / Sage Services Group
Sage Services Group: FDA-registered device maker in Charleston, SC, United States, 7 510(k) clearances
Sage Services Group is registered with the FDA (registration 3009191551) in Charleston, SC, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated February 6, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009191551
- Address
- 506 Deanna Ln, Charleston, SC, United States, 29492
- Owner or operator
- Sage Services Group (10039289)
- Roles
- Repackager or relabeler
- First device listed
- April 21, 2016
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| February 6, 2015 | K142832 | Unimed Disposable and Reusable SPO2 Sensors | DQA | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| November 4, 2014 | K142489 | Unimed Disposable ECG lead wires | DSA | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| May 29, 2012 | K121427 | UNIMED TEMPERATURE PROBE | FLL | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| May 4, 2012 | K120364 | UNIMED DISPOSABLE BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| November 22, 2011 | K112544 | UNIMED BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| December 2, 2008 | K082546 | REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) | DQA | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| October 10, 2008 | K082959 | PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS | DSA | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Continuous Measurement Thermometer
- All makers of Oximeter
- All makers of Blood Pressure Cuff
Updated February 6, 2015. 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.