510(k) K852278

ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400 by Acme Medical Scale Co. — Product Code FRW

K852278 is an FDA 510(k) premarket notification submitted by Acme Medical Scale Co. for the device "ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400". The FDA issued a decision of Substantially Equivalent on June 7, 1985. 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
June 7, 1985
Date Received
May 29, 1985
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