Cleared Traditional

K760641 - MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N (FDA 510(k) Clearance)

K760641 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device

Oct 1976

Decision

24d

Days

Class 2

Risk

K760641 is an FDA 510(k) clearance for the MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N. This device is classified as a Injector, Contrast Medium, Automatic (Class II - Special Controls, product code IZQ).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 8, 1976, 24 days after receiving the submission on September 14, 1976.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K760641 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 14, 1976
Decision Date	October 08, 1976
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—