ULTRACOMPACT— 510(k) K894968

Substantially Equivalent

Eutectic Electronics, Inc.

FDA 510(k) clearance K894968 for ULTRACOMPACT, Substantially Equivalent on 1989-11-08. Applicant: Eutectic Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Eutectic Electronics, Inc.
Product code: Code EXY
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1989-08-07
Decision date: 1989-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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