DOPSCAN MODEL 1050— 510(k) K810561

Name: FDA 510(k) clearance K810561
Creator: U.S. Food and Drug Administration
Published: 1981-04-10

Substantially Equivalent

Carolina Medical Electronics

FDA 510(k) clearance K810561 for DOPSCAN MODEL 1050, Substantially Equivalent on 1981-04-10. Applicant: Carolina Medical Electronics. Device class: 2.

Clearance details

Applicant: Carolina Medical Electronics
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 1981-03-03
Decision date: 1981-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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