510(k) K872742

WARM WEIGH MODELS I-20/W-30 INFANT SCALE by Air-Shields, Inc. — Product Code FMT

K872742 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "WARM WEIGH MODELS I-20/W-30 INFANT SCALE". The FDA issued a decision of Substantially Equivalent on October 20, 1987. 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
October 20, 1987
Date Received
July 10, 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