THE BREATHE EASE NURSERY VAPOR TENT
FDA 510(k) clearance K884922 · decided 1989-02-03
Clearance details
- K-number
- K884922
- Device name
- THE BREATHE EASE NURSERY VAPOR TENT
- Applicant
- Cal-Trends Products
- Decision
- Substantially Equivalent
- Date received
- 1988-11-28
- Decision date
- 1989-02-03
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- FNC
- Device class
- 2
- Regulation number
- 868.5710
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Fullerton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.