TRANSAMERICA DIGITAL EMS— 510(k) K010665

Name: FDA 510(k) clearance K010665
Creator: U.S. Food and Drug Administration
Published: 2001-04-27

Substantially Equivalent

Transamerica Medical Systems

FDA 510(k) clearance K010665 for TRANSAMERICA DIGITAL EMS, Substantially Equivalent on 2001-04-27. Applicant: Transamerica Medical Systems. Device class: 2.

Clearance details

Applicant: Transamerica Medical Systems
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2001-03-06
Decision date: 2001-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Holyoke, MA, US

Download summary PDF View on FDA.gov ↗

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