HPM 40 HEART PACEMAKER MONITOR— 510(k) K922742

Name: FDA 510(k) clearance K922742
Creator: U.S. Food and Drug Administration
Published: 1993-03-18

Substantially Equivalent

Biotronik, GmbH & Co.

FDA 510(k) clearance K922742 for HPM 40 HEART PACEMAKER MONITOR, Substantially Equivalent on 1993-03-18. Applicant: Biotronik, GmbH & Co.. Device class: 2.

Clearance details

Applicant: Biotronik, GmbH & Co.
Product code: Code KRE
Device class: Class 2
Regulation: 21 CFR 870.3640
Advisory panel: Cardiovascular
Date received: 1992-06-08
Decision date: 1993-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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