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FDA 510(k)

LINA XCISE MODEL MOR-1515

K-Number: K101458 · 2011-03-11

ApplicantLina Medical Aps
Decision Date2011-03-11
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LINA XCISE MODEL MOR-1515 is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2011-03-11 under 510(k) number K101458. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINA XCISE MODEL MOR-1515?

LINA XCISE MODEL MOR-1515 is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is Lina Medical Aps. The 510(k) number is K101458.

When did LINA XCISE MODEL MOR-1515 receive FDA 510(k) clearance?

LINA XCISE MODEL MOR-1515 received FDA 510(k) clearance on 2011-03-11, under 510(k) number K101458.

Who is the listed applicant for LINA XCISE MODEL MOR-1515?

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

What is the FDA product code for LINA XCISE MODEL MOR-1515?

The FDA product code for LINA XCISE MODEL MOR-1515 is HET.

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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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