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FDA 510(k)

SONOLAYER - V, SSA-100A.

K-Number: K863269 · 1987-07-22

ApplicantToshiba Medical Systems
Decision Date1987-07-22
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOLAYER - V, SSA-100A. 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 1987-07-22 under 510(k) number K863269. 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 SONOLAYER - V, SSA-100A.?

SONOLAYER - V, SSA-100A. is a medical device that received FDA 510(k) clearance on 1987-07-22. The listed applicant is Toshiba Medical Systems. The 510(k) number is K863269.

When did SONOLAYER - V, SSA-100A. receive FDA 510(k) clearance?

SONOLAYER - V, SSA-100A. received FDA 510(k) clearance on 1987-07-22, under 510(k) number K863269.

Who is the listed applicant for SONOLAYER - V, SSA-100A.?

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 - V, SSA-100A.?

The FDA product code for SONOLAYER - V, SSA-100A. 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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