ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522— 510(k) K982216

Name: FDA 510(k) clearance K982216
Creator: U.S. Food and Drug Administration
Published: 1998-09-11

Substantially Equivalent

Braebon Medical Corp.

FDA 510(k) clearance K982216 for ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522, Substantially Equivalent on 1998-09-11. Applicant: Braebon Medical Corp.. Device class: 2.

Clearance details

Applicant: Braebon Medical Corp.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1998-06-23
Decision date: 1998-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanata, CA

Download summary PDF View on FDA.gov ↗

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