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FDA 510(k)

S-SCAN, MODEL 9800020010

K-Number: K100670 · 2010-04-05

ApplicantEsaote, S.p.A.
Decision Date2010-04-05
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

S-SCAN, MODEL 9800020010 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2010-04-05 under 510(k) number K100670. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-SCAN, MODEL 9800020010?

S-SCAN, MODEL 9800020010 is a medical device that received FDA 510(k) clearance on 2010-04-05. The listed applicant is Esaote, S.p.A.. The 510(k) number is K100670.

When did S-SCAN, MODEL 9800020010 receive FDA 510(k) clearance?

S-SCAN, MODEL 9800020010 received FDA 510(k) clearance on 2010-04-05, under 510(k) number K100670.

Who is the listed applicant for S-SCAN, MODEL 9800020010?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-SCAN, MODEL 9800020010?

The FDA product code for S-SCAN, MODEL 9800020010 is MOS.

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Related Devices (Code: MOS)

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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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