PROGRAMALITH PROGRAMMER— 510(k) K823242

Substantially Equivalent

Pacesetter Systems

FDA 510(k) clearance K823242 for PROGRAMALITH PROGRAMMER, Substantially Equivalent on 1983-01-08. Applicant: Pacesetter Systems. Device class: 2.

Clearance details

Applicant: Pacesetter Systems
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 1982-11-01
Decision date: 1983-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K895447 — ENDOCARDIAL SCREW-IN LEAD MODEL 1020T1989-12-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.