Data / Medical devices / Peru / Hyperbaric S.A.C.
Hyperbaric S.A.C.: FDA-registered device maker in Lima Lima(Region), Peru, 1 510(k) clearance
Hyperbaric S.A.C. is registered with the FDA (registration 3007127387) in Lima Lima(Region), Peru. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 25, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007127387
- Address
- AV. PEDRO HUILCA MZ. C, LOTE 9 Parque Ind PARQUE INDUSTRIAL, PARC II, VILLA EL SALVADOR, Lima Lima(Region), Peru, 15816
- Owner or operator
- Hyperbaric S.A.C. (10026695)
- Roles
- Manufacturer
- First device listed
- August 12, 2008
- Registered through
- 2026
- Brand names listed
- OXICAB ML-4BZ-18, OXICAB ML-60, OXICAB MO-13
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 |
|---|---|---|---|---|---|---|
| July 25, 2008 | K081506 | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS | CBF | Substantially Equivalent | Hyperbaric America, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 25, 2008. 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.