510(k) K841534

ACME DIGITAL INFANT SCALE-30 by Acme Medical Scale Co. — Product Code FRW

K841534 is an FDA 510(k) premarket notification submitted by Acme Medical Scale Co. for the device "ACME DIGITAL INFANT SCALE-30". The FDA issued a decision of Substantially Equivalent on May 31, 1984. 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
May 31, 1984
Date Received
April 16, 1984
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