MAXAIR SURGICAL HELMET SYSTEM
FDA 510(k) clearance K040485 · decided 2004-10-18
Clearance details
- K-number
- K040485
- Device name
- MAXAIR SURGICAL HELMET SYSTEM
- Applicant
- Bio-Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-25
- Decision date
- 2004-10-18
- Days to decision
- 236 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 recall (Z-0835-2023) | Biomerieux Inc | 2023-01-04 |