MODEL 450 INFRARED IMAGING SYSTEM— 510(k) K861534

Name: FDA 510(k) clearance K861534
Creator: U.S. Food and Drug Administration
Published: 1986-07-18

Substantially Equivalent for Some Indications

Mitek , Inc.

FDA 510(k) clearance K861534 for MODEL 450 INFRARED IMAGING SYSTEM, Substantially Equivalent for Some Indications on 1986-07-18. Applicant: Mitek , Inc.. Device class: 1.

Clearance details

Applicant: Mitek , Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1986-04-24
Decision date: 1986-07-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Marquette, MI, US

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