Data / Medical devices / United States / Hyperbaric Technologies, Inc.
Hyperbaric Technologies, Inc.: FDA-registered device maker in Amsterdam, NY, United States, 1 510(k) clearance
Hyperbaric Technologies, Inc. is registered with the FDA (registration 2438426) in Amsterdam, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 2, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2438426
- FEI number
- 1000624398
- Address
- One Sam Stratton RD., Amsterdam, NY, United States, 12010
- Owner or operator
- HYPERBARIC TECHNOLOGIES, INC. (9039459)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 1, 1999
- Registered through
- 2026
- Brand names listed
- QUAMVIS, RESPIRO, SOLACE, VITAERIS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Hyperbaric | CBF | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 2, 2000 | K001409 | GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER | CBF | Substantially Equivalent | Hyperbaric Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 2, 2000. 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.