PMI100 VIDEO IMAGER— 510(k) K925220

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K925220 for PMI100 VIDEO IMAGER, Substantially Equivalent on 1993-05-20. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code LMC
Device class: Class 2
Regulation: 21 CFR 892.2040
Advisory panel: Radiology
Date received: 1992-10-16
Decision date: 1993-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

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