OTOSCOPE— 510(k) K902205

Substantially Equivalent

Truphatek, Ltd.

FDA 510(k) clearance K902205 for OTOSCOPE, Substantially Equivalent on 1990-08-14. Applicant: Truphatek, Ltd.. Device class: 1.

Clearance details

Applicant: Truphatek, Ltd.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1990-05-16
Decision date: 1990-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

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