Data / Medical devices / Malaysia / Dispo-Med (malaysia) Sdn Bhd
Dispo-Med (malaysia) Sdn Bhd: FDA-registered device maker in Shah Alam Selangor, Malaysia, 1 510(k) clearance
Dispo-Med (malaysia) Sdn Bhd is registered with the FDA (registration 9710116) in Shah Alam Selangor, Malaysia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710116
- FEI number
- 3003348851
- Address
- No. 3, Jalan Meteor U16/153A, Elmina Sekysen 16, Shah Alam Selangor, Malaysia, 40160
- Owner or operator
- Dispo-Med (MALAYSIA) SDN BHD (10048710)
- Roles
- Manufacturer
- First device listed
- February 16, 2015
- Registered through
- 2026
- Brand names listed
- CO2 Sampling Cannula w/ O2 Delivery Line, CO2-MAS Capnomask O2 + CO2 Sampling Mask, DM-1000 Nasal CO2 Sampling Line, DM-4000 Nasal CO2 Sampling Cannula w/ O2 Delivery, DM-4100 CO2 Sampling Cannula with Filter, DM-4441 LO-FLO CO2 Sampling Cannual with Dual O2 Delivery, DM-4601 Nasal/Oral O2 and CO2 Sampling Cannula, DM-6500 DUO Flow O2 and CO2 Sampling Cannula and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | 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 13, 2015 | K143127 | CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style | CCK | Substantially Equivalent | Dispo-Med (Malaysia) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Mask, Oxygen
Updated February 13, 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.