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FDA 510(k)

MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001

K-Number: K053325 · 2005-12-07

ApplicantMediwatch, Ltd.
Decision Date2005-12-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 is the device name listed in this FDA 510(k) record. The listed applicant is Mediwatch, Ltd.. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K053325. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001?

MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is Mediwatch, Ltd.. The 510(k) number is K053325.

When did MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 receive FDA 510(k) clearance?

MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 received FDA 510(k) clearance on 2005-12-07, under 510(k) number K053325.

Who is the listed applicant for MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001?

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

What is the FDA product code for MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001?

The FDA product code for MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 is IYO.

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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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