Cleared Traditional

K020550: PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX

K020550 · Datascope Corp. · Cardiovascular

Aug 2002

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K020550 is an FDA 510(k) clearance for the PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Datascope Corp. (Mahwah, US). The FDA issued a Cleared decision on August 28, 2002, 190 days after receiving the submission on February 19, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K020550 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2002
Decision Date	August 28, 2002
Days to Decision	190 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF