ULTIMA SMARTBELT, MODEL 0560— 510(k) K001743

Name: FDA 510(k) clearance K001743
Creator: U.S. Food and Drug Administration
Published: 2000-08-25

Substantially Equivalent

Braebon Medical Corp.

FDA 510(k) clearance K001743 for ULTIMA SMARTBELT, MODEL 0560, Substantially Equivalent on 2000-08-25. 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: 2000-06-08
Decision date: 2000-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Carp, Ontario, CA

Download summary PDF View on FDA.gov ↗

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