HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER— 510(k) K861505

Name: FDA 510(k) clearance K861505
Creator: U.S. Food and Drug Administration
Published: 1987-04-10

Substantially Equivalent

American Medical Equipment, Inc.

FDA 510(k) clearance K861505 for HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER, Substantially Equivalent on 1987-04-10. Applicant: American Medical Equipment, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Equipment, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1986-04-23
Decision date: 1987-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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