EXTERNAL PACEMAKER TELECTRONICS TE200— 510(k) K852746

Name: FDA 510(k) clearance K852746
Creator: U.S. Food and Drug Administration
Published: 1985-09-12

Substantially Equivalent

Seamed Corp.

FDA 510(k) clearance K852746 for EXTERNAL PACEMAKER TELECTRONICS TE200, Substantially Equivalent on 1985-09-12. Applicant: Seamed Corp.. Device class: 2.

Clearance details

Applicant: Seamed Corp.
Product code: Code JOQ
Device class: Class 2
Regulation: 21 CFR 870.1750
Advisory panel: Cardiovascular
Date received: 1985-06-27
Decision date: 1985-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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