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FDA 510(k)

BLADDERSCAN BVI 6100

K-Number: K022153 · 2002-08-15

ApplicantDiagnostic Ultrasound Corp.
Decision Date2002-08-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BLADDERSCAN BVI 6100 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 2002-08-15 under 510(k) number K022153. 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 6100?

BLADDERSCAN BVI 6100 is a medical device that received FDA 510(k) clearance on 2002-08-15. The listed applicant is Diagnostic Ultrasound Corp.. The 510(k) number is K022153.

When did BLADDERSCAN BVI 6100 receive FDA 510(k) clearance?

BLADDERSCAN BVI 6100 received FDA 510(k) clearance on 2002-08-15, under 510(k) number K022153.

Who is the listed applicant for BLADDERSCAN BVI 6100?

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 BLADDERSCAN BVI 6100?

The FDA product code for BLADDERSCAN BVI 6100 is IYO.

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Other records listing Diagnostic Ultrasound Corp. as applicant

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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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