510(k) K885350
K885350 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "PREEMICARE SERIES 2000 INFANT WARMER". The FDA issued a decision of Substantially Equivalent on August 7, 1989. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Preemicare Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1989
- Date Received
- December 28, 1988
- 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