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FDA 510(k)

VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND

K-Number: K090214 · 2009-03-13

ApplicantVerathon Incorporated
Decision Date2009-03-13
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERATHON INC. BLADDERSCAN BVM 9500 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 2009-03-13 under 510(k) number K090214. 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 VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND?

VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Verathon Incorporated. The 510(k) number is K090214.

When did VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND receive FDA 510(k) clearance?

VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND received FDA 510(k) clearance on 2009-03-13, under 510(k) number K090214.

Who is the listed applicant for VERATHON INC. BLADDERSCAN BVM 9500 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 VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND?

The FDA product code for VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND is IYO.

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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 SystemK082456VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600K071217BLADDERSCAN BVI 9400 ULTRASOUND

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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