Cleared Traditional

K772054 - PHYSIOLOGICAL RECORDER MODEL 740 (FDA 510(k) Clearance)

K772054 · Datascope Corp. · Cardiovascular device
Nov 1977
Decision
22d
Days
Class 1
Risk

K772054 is an FDA 510(k) clearance for the PHYSIOLOGICAL RECORDER MODEL 740. This device is classified as a Recorder, Paper Chart (Class I - General Controls, product code DSF).

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1977, 22 days after receiving the submission on October 31, 1977.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2810.

Submission Details

510(k) Number K772054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1977
Decision Date November 22, 1977
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -

Device Classification

Product Code DSF - Recorder, Paper Chart
Device Class Class I - General Controls
CFR Regulation 21 CFR 870.2810