DCATS— 510(k) K812799

Substantially Equivalent

Dorex, Inc.

FDA 510(k) clearance K812799 for DCATS, Substantially Equivalent on 1981-10-20. Applicant: Dorex, Inc.. Device class: 3.

Clearance details

Applicant: Dorex, Inc.
Product code: Code IYM
Device class: Class 3
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1981-10-06
Decision date: 1981-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYM

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K852950 — VISITHERM1986-02-07
K823041 — JEOL MODEL #JTG-500M1982-11-24
K812701 — ORTHO-THERM INFRARED SENSOR1981-10-13
K801553 — THERMOCOMP1980-10-31

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K023434 — DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM2002-11-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.