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FDA 510(k)

1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507

K-Number: K860621 · 1986-05-20

ApplicantImpex Medical Systems, Inc.
Decision Date1986-05-20
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 is the device name listed in this FDA 510(k) record. The listed applicant is Impex Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-05-20 under 510(k) number K860621. 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 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507?

1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 is a medical device that received FDA 510(k) clearance on 1986-05-20. The listed applicant is Impex Medical Systems, Inc.. The 510(k) number is K860621.

When did 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 receive FDA 510(k) clearance?

1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 received FDA 510(k) clearance on 1986-05-20, under 510(k) number K860621.

Who is the listed applicant for 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507?

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

What is the FDA product code for 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507?

The FDA product code for 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 is HGL.

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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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