P.R.M. 80— 510(k) K810590

Substantially Equivalent

T.E.M. Instruments , Ltd.

FDA 510(k) clearance K810590 for P.R.M. 80, Substantially Equivalent on 1981-04-10. Applicant: T.E.M. Instruments , Ltd.. Device class: 2.

Clearance details

Applicant: T.E.M. Instruments , Ltd.
Product code: Code IZW
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 1981-03-04
Decision date: 1981-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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