Cleared Traditional

K926174 - MODEL 9100 H.R. INFANT SCALE
(FDA 510(k) Clearance)

Oct 1993
Decision
321d
Days
Class 1
Risk

K926174 is an FDA 510(k) clearance for the MODEL 9100 H.R. INFANT SCALE. 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 October 25, 1993, 321 days after receiving the submission on December 8, 1992.

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

Submission Details

510(k) Number K926174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date October 25, 1993
Days to Decision 321 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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