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FDA 510(k)

VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001

K-Number: K051920 · 2005-08-19

ApplicantVolcano Corporation
Decision Date2005-08-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2005-08-19 under 510(k) number K051920. 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 VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001?

VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 is a medical device that received FDA 510(k) clearance on 2005-08-19. The listed applicant is Volcano Corporation. The 510(k) number is K051920.

When did VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 receive FDA 510(k) clearance?

VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 received FDA 510(k) clearance on 2005-08-19, under 510(k) number K051920.

Who is the listed applicant for VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001?

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

What is the FDA product code for VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001?

The FDA product code for VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 is IYO.

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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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