Cleared Traditional

K931605 - 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE
(FDA 510(k) Clearance)

Jul 1993
Decision
110d
Days
Class 1
Risk

K931605 is an FDA 510(k) clearance for the 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE. This device is classified as a Film, Radiographic (Class I - General Controls, product code IWZ).

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on July 20, 1993, 110 days after receiving the submission on April 1, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1840.

Submission Details

510(k) Number K931605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1993
Decision Date July 20, 1993
Days to Decision 110 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IWZ — Film, Radiographic
Device Class Class I - General Controls
CFR Regulation 21 CFR 892.1840