MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
FDA 510(k) clearance K003455 · decided 2000-12-06
Clearance details
- K-number
- K003455
- Device name
- MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
- Applicant
- Chad Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-07
- Decision date
- 2000-12-06
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- NFB
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***. recall (Z-1068-05) | Chad Therapeutics Inc | 2005-08-03 |