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FDA 510(k)

SONOLAYER ALPHA, MODEL SSH-140A

K-Number: K913798 · 1992-04-01

ApplicantToshiba America Medical Systems, In.C
Decision Date1992-04-01
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOLAYER ALPHA, MODEL SSH-140A is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 1992-04-01 under 510(k) number K913798. 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 ALPHA, MODEL SSH-140A?

SONOLAYER ALPHA, MODEL SSH-140A is a medical device that received FDA 510(k) clearance on 1992-04-01. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K913798.

When did SONOLAYER ALPHA, MODEL SSH-140A receive FDA 510(k) clearance?

SONOLAYER ALPHA, MODEL SSH-140A received FDA 510(k) clearance on 1992-04-01, under 510(k) number K913798.

Who is the listed applicant for SONOLAYER ALPHA, MODEL SSH-140A?

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

What is the FDA product code for SONOLAYER ALPHA, MODEL SSH-140A?

The FDA product code for SONOLAYER ALPHA, MODEL SSH-140A is ITX.

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Related Devices (Code: 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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