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FDA 510(k)

STRATA, MODEL V.O.95

K-Number: K981678 · 1998-12-11

ApplicantRosses Medical Systems
Decision Date1998-12-11
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STRATA, MODEL V.O.95 is the device name listed in this FDA 510(k) record. The listed applicant is Rosses Medical Systems. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K981678. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATA, MODEL V.O.95?

STRATA, MODEL V.O.95 is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Rosses Medical Systems. The 510(k) number is K981678.

When did STRATA, MODEL V.O.95 receive FDA 510(k) clearance?

STRATA, MODEL V.O.95 received FDA 510(k) clearance on 1998-12-11, under 510(k) number K981678.

Who is the listed applicant for STRATA, MODEL V.O.95?

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

What is the FDA product code for STRATA, MODEL V.O.95?

The FDA product code for STRATA, MODEL V.O.95 is MUJ.

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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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