510(k) K926174

MODEL 9100 H.R. INFANT SCALE by Acme Medical Scale Co. — Product Code FRW

K926174 is an FDA 510(k) premarket notification submitted by Acme Medical Scale Co. for the device "MODEL 9100 H.R. INFANT SCALE". The FDA issued a decision of Substantially Equivalent on October 25, 1993. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Acme Medical Scale Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1993
Date Received
December 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scale, Patient
Device Class
Class I
Regulation Number
880.2720
Review Panel
HO
Submission Type