ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM— 510(k) K974200

Name: FDA 510(k) clearance K974200
Creator: U.S. Food and Drug Administration
Published: 1998-07-21

Substantially Equivalent

Orca Diagnostics Corp.

FDA 510(k) clearance K974200 for ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM, Substantially Equivalent on 1998-07-21. Applicant: Orca Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Orca Diagnostics Corp.
Product code: Code BZM
Device class: Class 2
Regulation: 21 CFR 868.1900
Advisory panel: Anesthesiology
Date received: 1997-11-10
Decision date: 1998-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Altos, CA, US

Download summary PDF View on FDA.gov ↗

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