EAR OXIMETER— 510(k) K810363

Substantially Equivalent

Bio-Tek Instruments, Inc.

FDA 510(k) clearance K810363 for EAR OXIMETER, Substantially Equivalent on 1981-02-27. Applicant: Bio-Tek Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Tek Instruments, Inc.
Product code: Code DPZ
Device class: Class 2
Regulation: 21 CFR 870.2710
Advisory panel: Cardiovascular
Date received: 1981-02-11
Decision date: 1981-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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