510(k) K032989

MEDI-HEAT INFANT HEEL WARMER by Mediheat, Inc. — Product Code MPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2003
Date Received
September 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infant Heel Warmer (Chemical Heat Pack)
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type