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FDA 510(k)

MOBIUS ULTRASOUND IMAGING SYSTEM

K-Number: K102153 · 2011-01-20

ApplicantMobisante, Inc.
Decision Date2011-01-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBIUS ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mobisante, Inc.. It received FDA 510(k) clearance on 2011-01-20 under 510(k) number K102153. 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 MOBIUS ULTRASOUND IMAGING SYSTEM?

MOBIUS ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-20. The listed applicant is Mobisante, Inc.. The 510(k) number is K102153.

When did MOBIUS ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

MOBIUS ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2011-01-20, under 510(k) number K102153.

Who is the listed applicant for MOBIUS ULTRASOUND IMAGING SYSTEM?

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

What is the FDA product code for MOBIUS ULTRASOUND IMAGING SYSTEM?

The FDA product code for MOBIUS ULTRASOUND IMAGING SYSTEM is IYO.

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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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