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FDA 510(k)

MOBETRON

K-Number: K981112 · 1998-07-24

ApplicantIntraop Medical, Inc.
Decision Date1998-07-24
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBETRON is the device name listed in this FDA 510(k) record. The listed applicant is Intraop Medical, Inc.. It received FDA 510(k) clearance on 1998-07-24 under 510(k) number K981112. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBETRON?

MOBETRON is a medical device that received FDA 510(k) clearance on 1998-07-24. The listed applicant is Intraop Medical, Inc.. The 510(k) number is K981112.

When did MOBETRON receive FDA 510(k) clearance?

MOBETRON received FDA 510(k) clearance on 1998-07-24, under 510(k) number K981112.

Who is the listed applicant for MOBETRON?

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

What is the FDA product code for MOBETRON?

The FDA product code for MOBETRON is LHN.

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Related Devices (Code: LHN)

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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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