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FDA 510(k)

COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER

K-Number: K940942 · 1997-02-19

ApplicantMedison America, Inc.
Decision Date1997-02-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 1997-02-19 under 510(k) number K940942. 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 COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER?

COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 1997-02-19. The listed applicant is Medison America, Inc.. The 510(k) number is K940942.

When did COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER receive FDA 510(k) clearance?

COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER received FDA 510(k) clearance on 1997-02-19, under 510(k) number K940942.

Who is the listed applicant for COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER?

The FDA 510(k) record lists Medison America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER?

The FDA product code for COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER 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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