ASC-950 ECG AMPLIFIER— 510(k) K894161

Substantially Equivalent

Astro-Med, Inc.

FDA 510(k) clearance K894161 for ASC-950 ECG AMPLIFIER, Substantially Equivalent on 1989-08-03. Applicant: Astro-Med, Inc.. Device class: 2.

Clearance details

Applicant: Astro-Med, Inc.
Product code: Code DRR
Device class: Class 2
Regulation: 21 CFR 870.2050
Advisory panel: Cardiovascular
Date received: 1989-06-14
Decision date: 1989-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Warwick, RI, US

Download summary PDF View on FDA.gov ↗

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