HEALTH MASK
FDA 510(k) clearance K070467 · decided 2007-04-17
Clearance details
- K-number
- K070467
- Device name
- HEALTH MASK
- Applicant
- Polar Wrap, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-02-16
- Decision date
- 2007-04-17
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- OBN
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.