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FDA 510(k)

SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.

K-Number: K931021 · 1994-11-14

ApplicantShimadzu Medical Systems
Decision Date1994-11-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Medical Systems. It received FDA 510(k) clearance on 1994-11-14 under 510(k) number K931021. 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 SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.?

SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. is a medical device that received FDA 510(k) clearance on 1994-11-14. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K931021.

When did SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. receive FDA 510(k) clearance?

SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. received FDA 510(k) clearance on 1994-11-14, under 510(k) number K931021.

Who is the listed applicant for SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.?

The FDA 510(k) record lists Shimadzu Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.?

The FDA product code for SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. is IYO.

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Other records listing Shimadzu Medical Systems 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.

K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONICK071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100K071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

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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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