510(k) K033040

PHOENIX INFANT RADIANT WARMER, MODEL 100NWS by International Hospital Supply Co. — Product Code FMT

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