Hyperbaric Modular Systems, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1000519737 | 1000519737 | Hyperbaric Modular Systems, Inc. | 1 | N | 2026-01-01 | 1663 Pacific Rim Ct. San Diego CA US 92154 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 110026 | 1743790644 | K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | CBF | 2017-03-22 |
| 110026 | 1853631151 | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System | CBF | 2016-04-29 |
| 110026 | 1067850642 | K052866 | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER | CBF | 2005-12-13 |
| 110026 | 1781475152 | K011866 | OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES | CBF | 2002-06-06 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CBF | 8 | 2017-03-22 |