510(k) K875270
K875270 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Air-Shields, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 1988
- Date Received
- December 22, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Infant Radiant
- Device Class
- Class II
- Regulation Number
- 880.5130
- Review Panel
- HO
- Submission Type