ETP 180 CARDIAC PACEMAKER (EXTERNAL)— 510(k) K860551

Name: FDA 510(k) clearance K860551
Creator: U.S. Food and Drug Administration
Published: 1986-04-30

Substantially Equivalent

Biotronics Corp.

FDA 510(k) clearance K860551 for ETP 180 CARDIAC PACEMAKER (EXTERNAL), Substantially Equivalent on 1986-04-30. Applicant: Biotronics Corp.. Device class: 2.

Clearance details

Applicant: Biotronics Corp.
Product code: Code DRO
Device class: Class 2
Regulation: 21 CFR 870.5550
Advisory panel: Cardiovascular
Date received: 1986-02-13
Decision date: 1986-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tualatin, OR, US

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