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FDA 510(k)

7.5 MHZ ENDORECTAL PROBE

K-Number: K881028 · 1988-04-27

ApplicantPhilips Ultrasound, Inc.
Decision Date1988-04-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

7.5 MHZ ENDORECTAL PROBE 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 1988-04-27 under 510(k) number K881028. 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 7.5 MHZ ENDORECTAL PROBE?

7.5 MHZ ENDORECTAL PROBE is a medical device that received FDA 510(k) clearance on 1988-04-27. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K881028.

When did 7.5 MHZ ENDORECTAL PROBE receive FDA 510(k) clearance?

7.5 MHZ ENDORECTAL PROBE received FDA 510(k) clearance on 1988-04-27, under 510(k) number K881028.

Who is the listed applicant for 7.5 MHZ ENDORECTAL PROBE?

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 7.5 MHZ ENDORECTAL PROBE?

The FDA product code for 7.5 MHZ ENDORECTAL PROBE 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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