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FDA 510(k)

MODEL STT-100

K-Number: K904853 · 1991-05-15

ApplicantSonocare, Inc.
Decision Date1991-05-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL STT-100 is the device name listed in this FDA 510(k) record. The listed applicant is Sonocare, Inc.. It received FDA 510(k) clearance on 1991-05-15 under 510(k) number K904853. 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 MODEL STT-100?

MODEL STT-100 is a medical device that received FDA 510(k) clearance on 1991-05-15. The listed applicant is Sonocare, Inc.. The 510(k) number is K904853.

When did MODEL STT-100 receive FDA 510(k) clearance?

MODEL STT-100 received FDA 510(k) clearance on 1991-05-15, under 510(k) number K904853.

Who is the listed applicant for MODEL STT-100?

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

What is the FDA product code for MODEL STT-100?

The FDA product code for MODEL STT-100 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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