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FDA 510(k)

ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE

K-Number: K875251 · 1988-05-11

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1988-05-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K875251. 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 ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE?

ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K875251.

When did ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE receive FDA 510(k) clearance?

ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE received FDA 510(k) clearance on 1988-05-11, under 510(k) number K875251.

Who is the listed applicant for ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE?

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

What is the FDA product code for ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE?

The FDA product code for ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE 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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