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FDA 510(k)

BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000

K-Number: K955840 · 1996-05-24

ApplicantDiagnostic Ultrasound Corp.
Decision Date1996-05-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Ultrasound Corp.. It received FDA 510(k) clearance on 1996-05-24 under 510(k) number K955840. 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 BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000?

BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 is a medical device that received FDA 510(k) clearance on 1996-05-24. The listed applicant is Diagnostic Ultrasound Corp.. The 510(k) number is K955840.

When did BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 receive FDA 510(k) clearance?

BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 received FDA 510(k) clearance on 1996-05-24, under 510(k) number K955840.

Who is the listed applicant for BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000?

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

What is the FDA product code for BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000?

The FDA product code for BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 is IYO.

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Other records listing Diagnostic Ultrasound Corp. 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.

K030763DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEMK022153BLADDERSCAN BVI 6100K982568BLADDERMANAGER PCI 5000 MODEL 1002K963585BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000K955942BLADDERSCAN BVI 5000K920664DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION

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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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