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FDA 510(k)

SDR 3500 (PHILIPS PLATINUM +)

K-Number: K873937 · 1988-03-23

ApplicantPhilips Ultrasound, Inc.
Decision Date1988-03-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SDR 3500 (PHILIPS PLATINUM +) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 1988-03-23 under 510(k) number K873937. 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 SDR 3500 (PHILIPS PLATINUM +)?

SDR 3500 (PHILIPS PLATINUM +) is a medical device that received FDA 510(k) clearance on 1988-03-23. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K873937.

When did SDR 3500 (PHILIPS PLATINUM +) receive FDA 510(k) clearance?

SDR 3500 (PHILIPS PLATINUM +) received FDA 510(k) clearance on 1988-03-23, under 510(k) number K873937.

Who is the listed applicant for SDR 3500 (PHILIPS PLATINUM +)?

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

What is the FDA product code for SDR 3500 (PHILIPS PLATINUM +)?

The FDA product code for SDR 3500 (PHILIPS PLATINUM +) 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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