MODEL 220 PATIENT MAGNET— 510(k) K092364

Substantially Equivalent

Cyberonics, Inc.

FDA 510(k) clearance K092364 for MODEL 220 PATIENT MAGNET, Substantially Equivalent on 2009-11-03. Applicant: Cyberonics, Inc.. Device class: 1.

Clearance details

Applicant: Cyberonics, Inc.
Product code: Code DTG
Device class: Class 1
Regulation: 21 CFR 870.3690
Advisory panel: Cardiovascular
Date received: 2009-08-05
Decision date: 2009-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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K831926 — IMPLANTABLE ENDOCARDIAL PACING LEADS1984-03-12
K813153 — TEST MAGNET1981-12-02

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