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FDA 510(k)

MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458

K-Number: K082011 · 2008-11-28

ApplicantBio-Medical Research, Ltd.
Decision Date2008-11-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2008-11-28 under 510(k) number K082011. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458?

MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 is a medical device that received FDA 510(k) clearance on 2008-11-28. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K082011.

When did MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 receive FDA 510(k) clearance?

MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 received FDA 510(k) clearance on 2008-11-28, under 510(k) number K082011.

Who is the listed applicant for MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458?

The FDA 510(k) record lists Bio-Medical Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458?

The FDA product code for MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 is GZJ.

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Official Source

View on FDA Database →

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

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