Cleared Traditional

K761147 - RELIANCE MOD-U-LINE M-700
(FDA 510(k) Clearance)

Jan 1977
Decision
63d
Days
Class 2
Risk

K761147 is an FDA 510(k) clearance for the RELIANCE MOD-U-LINE M-700. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).

Submitted by F. & F. Koenigkramer (Mchenry, US). The FDA issued a Cleared decision on January 28, 1977, 63 days after receiving the submission on November 26, 1976.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number K761147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1976
Decision Date January 28, 1977
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FPO — Stretcher, Wheeled
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6910

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