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FDA 510(k)

MODEL 220 PATIENT MAGNET

K-Number: K092364 · 2009-11-03

ApplicantCyberonics, Inc.
Decision Date2009-11-03
Product CodeDTG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 220 PATIENT MAGNET is the device name listed in this FDA 510(k) record. The listed applicant is Cyberonics, Inc.. It received FDA 510(k) clearance on 2009-11-03 under 510(k) number K092364. The device is classified under product code DTG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 220 PATIENT MAGNET?

MODEL 220 PATIENT MAGNET is a medical device that received FDA 510(k) clearance on 2009-11-03. The listed applicant is Cyberonics, Inc.. The 510(k) number is K092364.

When did MODEL 220 PATIENT MAGNET receive FDA 510(k) clearance?

MODEL 220 PATIENT MAGNET received FDA 510(k) clearance on 2009-11-03, under 510(k) number K092364.

Who is the listed applicant for MODEL 220 PATIENT MAGNET?

The FDA 510(k) record lists Cyberonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 220 PATIENT MAGNET?

The FDA product code for MODEL 220 PATIENT MAGNET is DTG.

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Related Devices (Code: DTG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960849MAGNO ALARMCardiac Assist Devices, Inc.K895110MAESTRO PACEMAKER TEST MAGNETCardiac Control Systems, Inc.K831926IMPLANTABLE ENDOCARDIAL PACING LEADSOscor, Inc.K813153TEST MAGNETPacesetter Systems

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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