OXYMIZER-PENDANT
FDA 510(k) clearance K834588 · decided 1984-03-19
Clearance details
- K-number
- K834588
- Device name
- OXYMIZER-PENDANT
- Applicant
- Chad Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-29
- Decision date
- 1984-03-19
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- NFB
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.