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FDA 510(k)

SONACE 2000

K-Number: K923246 · 1993-05-20

ApplicantMedison Co., Ltd.
Decision Date1993-05-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONACE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Medison Co., Ltd.. It received FDA 510(k) clearance on 1993-05-20 under 510(k) number K923246. 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 SONACE 2000?

SONACE 2000 is a medical device that received FDA 510(k) clearance on 1993-05-20. The listed applicant is Medison Co., Ltd.. The 510(k) number is K923246.

When did SONACE 2000 receive FDA 510(k) clearance?

SONACE 2000 received FDA 510(k) clearance on 1993-05-20, under 510(k) number K923246.

Who is the listed applicant for SONACE 2000?

The FDA 510(k) record lists Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONACE 2000?

The FDA product code for SONACE 2000 is IYO.

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Other records listing Medison Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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