Cleared Traditional

DATASCOPE 6000 MONITOR

K926099 · Datascope Corp. · Cardiovascular

Aug 1993

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K926099 is an FDA 510(k) clearance for the DATASCOPE 6000 MONITOR, a Monitor, St Segment (Class II — Special Controls, product code MLC), submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on August 6, 1993, 246 days after receiving the submission on December 3, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K926099 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 1992
Decision Date	August 06, 1993
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement