Data / Medical devices / Malaysia / Masimo Medical Technologies (Malaysia) SDN BHD
Masimo Medical Technologies (Malaysia) SDN BHD: FDA-registered device maker in Pasir Gudang Johor, Malaysia, 12 510(k) clearances
Masimo Medical Technologies (Malaysia) SDN BHD is registered with the FDA (registration 3027256461) in Pasir Gudang Johor, Malaysia. It lists 23 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 12, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027256461
- Address
- Lot 198511 (PLO 547-A) & Lot 198512 (PLO 547-B), Jalan Keluli 11, Zon 12A Kawasan Perindustrian Pasir Gudang, Pasir Gudang Johor, Malaysia, 81700
- Owner or operator
- MASIMO CORPORATION (9031881)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 30, 1999
- Registered through
- 2027
- Brand names listed
- DBI-dc, ISA AX+ Module, ISA CO2 Module, LNCS Blue, LNCS DBI, LNCS Disposable Sensors, LNCS E1, LNCS Patient Cables and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 12, 2023 | DEN200076 | ORi | QWE | Unknown | Masimo Corporation | accessdata.fda.gov |
| December 27, 2019 | K191059 | Masimo Rad-97 and Accessories | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| October 23, 2018 | K180046 | Masimo Rad-97 and Accessories | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| November 17, 2017 | K171121 | Masimo Root Monitoring System and Accessories | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| November 23, 2016 | K160940 | Masimo Disposable Transflectance Forehead Sensor | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 24, 2012 | K121912 | E1 EAR SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| February 24, 2012 | K113596 | MASIMO SET REUSABLE OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| September 23, 2011 | K111888 | MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| October 21, 2010 | K101896 | MASIMO LNCS/M-LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 15, 2005 | K051439 | LNOP BLUE OXIMETRY SENSOR | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 12, 2005 | K051212 | MODIFICATION TO LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 29, 2004 | K041815 | LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corp. | accessdata.fda.gov |
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Updated October 12, 2023. 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.