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FDA 510(k)

SLED, FINGER, HANDLE

K-Number: K971942 · 1997-07-23

ApplicantBiosound Esaote, Inc.
Decision Date1997-07-23
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SLED, FINGER, HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Biosound Esaote, Inc.. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K971942. 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 SLED, FINGER, HANDLE?

SLED, FINGER, HANDLE is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Biosound Esaote, Inc.. The 510(k) number is K971942.

When did SLED, FINGER, HANDLE receive FDA 510(k) clearance?

SLED, FINGER, HANDLE received FDA 510(k) clearance on 1997-07-23, under 510(k) number K971942.

Who is the listed applicant for SLED, FINGER, HANDLE?

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

What is the FDA product code for SLED, FINGER, HANDLE?

The FDA product code for SLED, FINGER, HANDLE is ITX.

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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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