FDA 510(k) clearance · back to tracker

TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM

Titronics Research & Development Co. cleared K032471 on 2003-10-10, decision: substantially equivalent

K-number

K032471

Sponsor

Titronics Research & Development Co.

Device

TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

2003-10-10

Product code

LHQ

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.2980

Official FDA record

Open K032471on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.