QA-40M DEFIBRILLATOR TESTER— 510(k) K963190

Substantially Equivalent

Metron U.S., Inc.

FDA 510(k) clearance K963190 for QA-40M DEFIBRILLATOR TESTER, Substantially Equivalent on 1997-07-01. Applicant: Metron U.S., Inc.. Device class: 2.

Clearance details

Applicant: Metron U.S., Inc.
Product code: Code DRL
Device class: Class 2
Regulation: 21 CFR 870.5325
Advisory panel: Cardiovascular
Date received: 1996-08-15
Decision date: 1997-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Metron U.S., Inc.

K982020 — METRON QA-IDS I.V. PUMP TESTER1998-09-30
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K963198 — PS-41 6M PATIENT SIMULATOR1997-03-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.