DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
FDA 510(k) clearance K840817 · decided 1984-04-25
Clearance details
- K-number
- K840817
- Device name
- DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
- Applicant
- Hospitak, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-24
- Decision date
- 1984-04-25
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- KPJ
- Device class
- 2
- Regulation number
- 878.5650
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Wound Treatment System (VHT-200) (K250188) | Vaporox, Inc. | 2025-03-10 |
| VHT-200 Wound Treatment System (K212121) | Vaporox, Inc. | 2023-03-23 |
| EPIFLO-28 (K190742) | Neogenix, LLC Dba Ogenix | 2019-12-13 |
| NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP (K112634) | Inotec Amd , Ltd. | 2012-07-03 |
| EPIFLO(R) (K120764) | Neogenix, LLC | 2012-04-27 |
| TANSCU O2 (K090681) | Electrochemical Oxygen Concepts, Inc. | 2009-08-12 |
| HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM (K080966) | Aoti , Ltd. | 2008-08-06 |
| WHS-1000 WOUND HEALING SYSTEM (K050156) | Iyia Technologies, Inc. | 2005-06-17 |
| OXYBOX SYSTEM (K023456) | Oxyfast Corporation | 2003-02-24 |
| VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER (K022028) | Vascular One, Inc. | 2002-12-17 |
| HEC 1000 (K020466) | Metro Medical Equipment, Inc. | 2002-05-08 |
| OXYGENATOR (K002632) | Adjunctive Therapeutics, Inc. | 2001-10-25 |
Recalls involving this device
No recalls on record reference this clearance.