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FDA 510(k)

SAFERSONIC SONOGRAPHY COVER

K-Number: K092858 · 2009-11-10

ApplicantSafersonic Medizinprodukte GmbH
Decision Date2009-11-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SAFERSONIC SONOGRAPHY COVER is the device name listed in this FDA 510(k) record. The listed applicant is Safersonic Medizinprodukte GmbH. It received FDA 510(k) clearance on 2009-11-10 under 510(k) number K092858. 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 SAFERSONIC SONOGRAPHY COVER?

SAFERSONIC SONOGRAPHY COVER is a medical device that received FDA 510(k) clearance on 2009-11-10. The listed applicant is Safersonic Medizinprodukte GmbH. The 510(k) number is K092858.

When did SAFERSONIC SONOGRAPHY COVER receive FDA 510(k) clearance?

SAFERSONIC SONOGRAPHY COVER received FDA 510(k) clearance on 2009-11-10, under 510(k) number K092858.

Who is the listed applicant for SAFERSONIC SONOGRAPHY COVER?

The FDA 510(k) record lists Safersonic Medizinprodukte GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFERSONIC SONOGRAPHY COVER?

The FDA product code for SAFERSONIC SONOGRAPHY 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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