IMWXDOP IR— 510(k) K944196

Substantially Equivalent

Imex Medical Systems, Inc.

FDA 510(k) clearance K944196 for IMWXDOP IR, Substantially Equivalent on 1995-05-12. Applicant: Imex Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Imex Medical Systems, Inc.
Product code: Code JAF
Device class: Class 2
Regulation: 21 CFR 892.1540
Advisory panel: Radiology
Date received: 1994-08-29
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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