510(k) K884922
- Device
- THE BREATHE EASE NURSERY VAPOR TENT
- Applicant
- CAL-TRENDS PRODUCTS
- 510(k) number
- K884922
- Product code
- FNC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-03
- Date received
- 1988-11-28
- Regulation
- 868.5710
- Classification name
- Tent, Pediatric Aerosol
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN MORTON
- Address
- 825 N. Harbor Blvd. Fullerton CA US 92632 92632
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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