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FDA 510(k)

ULTRA-COVER PU-TRANSDUCER COVER

K-Number: K981069 · 1998-09-23

ApplicantInternational Medical Products B.V.
Decision Date1998-09-23
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRA-COVER PU-TRANSDUCER COVER is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Products B.V.. It received FDA 510(k) clearance on 1998-09-23 under 510(k) number K981069. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA-COVER PU-TRANSDUCER COVER?

ULTRA-COVER PU-TRANSDUCER COVER is a medical device that received FDA 510(k) clearance on 1998-09-23. The listed applicant is International Medical Products B.V.. The 510(k) number is K981069.

When did ULTRA-COVER PU-TRANSDUCER COVER receive FDA 510(k) clearance?

ULTRA-COVER PU-TRANSDUCER COVER received FDA 510(k) clearance on 1998-09-23, under 510(k) number K981069.

Who is the listed applicant for ULTRA-COVER PU-TRANSDUCER COVER?

The FDA 510(k) record lists International Medical Products B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA-COVER PU-TRANSDUCER COVER?

The FDA product code for ULTRA-COVER PU-TRANSDUCER COVER is ITX.

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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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