510(k) K884922
K884922 is an FDA 510(k) premarket notification submitted by Cal-Trends Products for the device "THE BREATHE EASE NURSERY VAPOR TENT". The FDA issued a decision of Substantially Equivalent on February 3, 1989. The device falls under product code FNC (Tent, Pediatric Aerosol), a Class II device regulated under 21 CFR 868.5710.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1989
- Date Received
- November 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tent, Pediatric Aerosol
- Device Class
- Class II
- Regulation Number
- 868.5710
- Review Panel
- AN
- Submission Type