The following data is part of a premarket notification filed by Hyperbaric America, Llc with the FDA for Hyperbaric America, Llc, Presidential Monoplace Hyperbaric Chamber Systems.
| Device ID | K081506 |
| 510k Number | K081506 |
| Device Name: | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS |
| Classification | Chamber, Hyperbaric |
| Applicant | HYPERBARIC AMERICA, LLC 1811 COPPER RIDGE DR. San Antonio, TX 78259 |
| Contact | Tom Workman |
| Correspondent | Tom Workman HYPERBARIC AMERICA, LLC 1811 COPPER RIDGE DR. San Antonio, TX 78259 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-29 |
| Decision Date | 2008-07-25 |
| Summary: | summary |