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FDA 510(k)

TRANSVAGINAL PROBE, MODEL ED65M-TV

K-Number: K861371 · 1986-07-14

ApplicantElscint, Inc.
Decision Date1986-07-14
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSVAGINAL PROBE, MODEL ED65M-TV is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1986-07-14 under 510(k) number K861371. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSVAGINAL PROBE, MODEL ED65M-TV?

TRANSVAGINAL PROBE, MODEL ED65M-TV is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is Elscint, Inc.. The 510(k) number is K861371.

When did TRANSVAGINAL PROBE, MODEL ED65M-TV receive FDA 510(k) clearance?

TRANSVAGINAL PROBE, MODEL ED65M-TV received FDA 510(k) clearance on 1986-07-14, under 510(k) number K861371.

Who is the listed applicant for TRANSVAGINAL PROBE, MODEL ED65M-TV?

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

What is the FDA product code for TRANSVAGINAL PROBE, MODEL ED65M-TV?

The FDA product code for TRANSVAGINAL PROBE, MODEL ED65M-TV is HGL.

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Other records listing Elscint, Inc. as applicant

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Related Devices (Code: HGL)

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.

K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.K924516OP3/VP4Huntleigh Technology, Inc.K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of AmericaK901142MER MULTIPLANE VAGINAL PROBE (MVP)Medical Equipment Resources

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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