Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE

K-Number: K870748 · 1987-04-10

Decision Date1987-04-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

7.5 MHZ TRANSRECTAL (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 1987-04-10 under 510(k) number K870748. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE?

7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE is a medical device that received FDA 510(k) clearance on 1987-04-10. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K870748.

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

7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE received FDA 510(k) clearance on 1987-04-10, under 510(k) number K870748.

Who is the listed applicant for 7.5 MHZ TRANSRECTAL (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 TRANSRECTAL (ENDORECTAL) PROBE?

The FDA product code for 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE is ITX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Philips Ultrasound, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 43 devices →

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

↑