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FDA 510(k)

BLADDERSCAN BVI 9400 ULTRASOUND

K-Number: K071217 · 2007-05-17

ApplicantVerathon Incorporated
Decision Date2007-05-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BLADDERSCAN BVI 9400 ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Verathon Incorporated. It received FDA 510(k) clearance on 2007-05-17 under 510(k) number K071217. 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 BLADDERSCAN BVI 9400 ULTRASOUND?

BLADDERSCAN BVI 9400 ULTRASOUND is a medical device that received FDA 510(k) clearance on 2007-05-17. The listed applicant is Verathon Incorporated. The 510(k) number is K071217.

When did BLADDERSCAN BVI 9400 ULTRASOUND receive FDA 510(k) clearance?

BLADDERSCAN BVI 9400 ULTRASOUND received FDA 510(k) clearance on 2007-05-17, under 510(k) number K071217.

Who is the listed applicant for BLADDERSCAN BVI 9400 ULTRASOUND?

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

What is the FDA product code for BLADDERSCAN BVI 9400 ULTRASOUND?

The FDA product code for BLADDERSCAN BVI 9400 ULTRASOUND is IYO.

Related Clinical Trials

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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Other records listing Verathon Incorporated 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.

K172356BladderScan Prime PLUS SystemK090214VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUNDK082456VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600

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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