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FDA 510(k)

SONOLAYER SAL-55A/55AS

K-Number: K853739 · 1986-02-24

ApplicantToshiba Medical Systems
Decision Date1986-02-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOLAYER SAL-55A/55AS 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 1986-02-24 under 510(k) number K853739. 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 SAL-55A/55AS?

SONOLAYER SAL-55A/55AS is a medical device that received FDA 510(k) clearance on 1986-02-24. The listed applicant is Toshiba Medical Systems. The 510(k) number is K853739.

When did SONOLAYER SAL-55A/55AS receive FDA 510(k) clearance?

SONOLAYER SAL-55A/55AS received FDA 510(k) clearance on 1986-02-24, under 510(k) number K853739.

Who is the listed applicant for SONOLAYER SAL-55A/55AS?

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 SAL-55A/55AS?

The FDA product code for SONOLAYER SAL-55A/55AS is IYO.

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Other records listing Toshiba Medical Systems as applicant

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K960948SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020AK954310BLA-800AK954309ANGIOREXK893750MRT-50A MOBILEK891453DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582VK890969TRANSESOPHAGEAL TRANSDUCER PEF-511SA

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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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