Cleared Traditional

K851014 - ACME LOW-PROFILE CHAIR SCAL 7300
(FDA 510(k) Clearance)

Mar 1985
Decision
15d
Days
Class 1
Risk

K851014 is an FDA 510(k) clearance for the ACME LOW-PROFILE CHAIR SCAL 7300. This device is classified as a Scale, Patient (Class I - General Controls, product code FRW).

Submitted by Acme Medical Scale Co. (San Leandro, US). The FDA issued a Cleared decision on March 27, 1985, 15 days after receiving the submission on March 12, 1985.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2720.

Submission Details

510(k) Number K851014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date March 27, 1985
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FRW — Scale, Patient
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.2720