510(k) K033040
K033040 is an FDA 510(k) premarket notification submitted by International Hospital Supply Co. for the device "PHOENIX INFANT RADIANT WARMER, MODEL 100NWS". The FDA issued a decision of Substantially Equivalent on Dec 17, 2003. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. International Hospital Supply Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2003
- Date Received
- Sep 29, 2003
- Clearance Type
- Abbreviated
- 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