Data / Medical devices / United States / Hyperbaric Modular Systems, Inc.
Hyperbaric Modular Systems, Inc.: FDA-registered device maker in San Diego, CA, United States, 4 510(k) clearances
Hyperbaric Modular Systems, Inc. is registered with the FDA (registration 1000519737) in San Diego, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated March 22, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000519737
- Address
- 1663 Pacific Rim Ct., San Diego, CA, United States, 92154
- Owner or operator
- HYPERBARIC MODULAR SYSTEMS, INC. (9012269)
- Roles
- Manufacturer
- First device listed
- November 8, 2007
- Registered through
- 2026
- Brand names listed
- HMS 1000 Monoplace Hyperbaric Chamber, HMS 2000 Hyperbaric Chamber, HMS 4000 Cylindrical Hyperbaric Chamber System Product Family, HMS 5000 Rectangular Hyperbaric Chamber System Product Family
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Hyperbaric | CBF | 2 | 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 |
|---|---|---|---|---|---|---|
| March 22, 2017 | K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | CBF | Substantially Equivalent | Oxyheal Medical Systems, Inc. | accessdata.fda.gov |
| April 29, 2016 | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System | CBF | Substantially Equivalent | Oxyheal Medical Systems, Inc. | accessdata.fda.gov |
| December 13, 2005 | K052866 | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER | CBF | Substantially Equivalent | Oxyheal Health Group | accessdata.fda.gov |
| June 6, 2002 | K011866 | OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES | CBF | Substantially Equivalent | Hyperbaric Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 22, 2017. 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.