TOF-WATCH— 510(k) K972698

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K972698 for TOF-WATCH, Substantially Equivalent on 1997-12-16. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code KOI
Advisory panel: Anesthesiology
Date received: 1997-07-18
Decision date: 1997-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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