RESPIRATION MONITOR TYPE MR-10— 510(k) K822077

Name: FDA 510(k) clearance K822077
Creator: U.S. Food and Drug Administration
Published: 1982-10-06

Substantially Equivalent

New Dimensions IN Medicine, Inc.

FDA 510(k) clearance K822077 for RESPIRATION MONITOR TYPE MR-10, Substantially Equivalent on 1982-10-06. Applicant: New Dimensions IN Medicine, Inc.. Device class: 2.

Clearance details

Applicant: New Dimensions IN Medicine, Inc.
Product code: Code FLS
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 1982-07-15
Decision date: 1982-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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