EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.— 510(k) K893561

Name: FDA 510(k) clearance K893561
Creator: U.S. Food and Drug Administration
Published: 1989-08-25

Substantially Equivalent

Edentec Corp.

FDA 510(k) clearance K893561 for EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM., Substantially Equivalent on 1989-08-25. Applicant: Edentec Corp.. Device class: 1.

Clearance details

Applicant: Edentec Corp.
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1989-05-09
Decision date: 1989-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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