ORBIT— 510(k) K120880

Name: FDA 510(k) clearance K120880
Creator: U.S. Food and Drug Administration
Published: 2012-04-19

Substantially Equivalent

National Biomedical, LLC Dba Qrs Diagnostic

FDA 510(k) clearance K120880 for ORBIT, Substantially Equivalent on 2012-04-19. Applicant: National Biomedical, LLC Dba Qrs Diagnostic. Device class: 2.

Clearance details

Applicant: National Biomedical, LLC Dba Qrs Diagnostic
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2012-03-23
Decision date: 2012-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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