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FDA 510(k)

SONOLAYER-L, SAL-77B

K-Number: K863947 · 1987-01-09

ApplicantToshiba Medical Systems
Decision Date1987-01-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOLAYER-L, SAL-77B is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems. It received FDA 510(k) clearance on 1987-01-09 under 510(k) number K863947. 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 SONOLAYER-L, SAL-77B?

SONOLAYER-L, SAL-77B is a medical device that received FDA 510(k) clearance on 1987-01-09. The listed applicant is Toshiba Medical Systems. The 510(k) number is K863947.

When did SONOLAYER-L, SAL-77B receive FDA 510(k) clearance?

SONOLAYER-L, SAL-77B received FDA 510(k) clearance on 1987-01-09, under 510(k) number K863947.

Who is the listed applicant for SONOLAYER-L, SAL-77B?

The FDA 510(k) record lists Toshiba Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOLAYER-L, SAL-77B?

The FDA product code for SONOLAYER-L, SAL-77B 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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