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FDA 510(k)

DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM

K-Number: K851860 · 1985-10-31

ApplicantDiasonics, Inc.
Decision Date1985-10-31
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1985-10-31 under 510(k) number K851860. 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 DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM?

DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1985-10-31. The listed applicant is Diasonics, Inc.. The 510(k) number is K851860.

When did DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1985-10-31, under 510(k) number K851860.

Who is the listed applicant for DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM?

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

What is the FDA product code for DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM?

The FDA product code for DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM is IYO.

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Other records listing Diasonics, Inc. 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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