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FDA 510(k)

MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)

K-Number: K981856 · 1998-07-29

ApplicantGreatbatch Scientific
Decision Date1998-07-29
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) is the device name listed in this FDA 510(k) record. The listed applicant is Greatbatch Scientific. It received FDA 510(k) clearance on 1998-07-29 under 510(k) number K981856. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)?

MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Greatbatch Scientific. The 510(k) number is K981856.

When did MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) receive FDA 510(k) clearance?

MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) received FDA 510(k) clearance on 1998-07-29, under 510(k) number K981856.

Who is the listed applicant for MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)?

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

What is the FDA product code for MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)?

The FDA product code for MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) is FET.

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Related Devices (Code: FET)

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.

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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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