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FDA 510(k)

NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A

K-Number: K043078 · 2004-11-17

ApplicantToshiba America Medical Systems, In.C
Decision Date2004-11-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A 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 2004-11-17 under 510(k) number K043078. 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 NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A?

NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A is a medical device that received FDA 510(k) clearance on 2004-11-17. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K043078.

When did NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A receive FDA 510(k) clearance?

NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A received FDA 510(k) clearance on 2004-11-17, under 510(k) number K043078.

Who is the listed applicant for NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A?

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 NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A?

The FDA product code for NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A 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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