MEDIBYTE, MODEL MP8— 510(k) K061764

Substantially Equivalent

Braebon Medical Corp.

FDA 510(k) clearance K061764 for MEDIBYTE, MODEL MP8, Substantially Equivalent on 2006-09-06. Applicant: Braebon Medical Corp.. Device class: 2.

Clearance details

Applicant: Braebon Medical Corp.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2006-06-22
Decision date: 2006-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carp, Ontario, CA

Download summary PDF View on FDA.gov ↗

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