Cleared Traditional

K760721 - MEDICAL OSCILLOSCOPE MEMORY SCOPE (FDA 510(k) Clearance)

Oct 1976
Decision
9d
Days
Class 2
Risk

K760721 is an FDA 510(k) clearance for the MEDICAL OSCILLOSCOPE MEMORY SCOPE. This device is classified as a Display, Cathode-ray Tube, Medical (Class II - Special Controls, product code DXJ).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 6, 1976, 9 days after receiving the submission on September 27, 1976.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K760721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1976
Decision Date October 06, 1976
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DXJ — Display, Cathode-ray Tube, Medical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2450