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FDA 510(k)

5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER

K-Number: K895123 · 1989-11-13

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1989-11-13
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1989-11-13 under 510(k) number K895123. 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 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER?

5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER is a medical device that received FDA 510(k) clearance on 1989-11-13. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K895123.

When did 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER receive FDA 510(k) clearance?

5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER received FDA 510(k) clearance on 1989-11-13, under 510(k) number K895123.

Who is the listed applicant for 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER?

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

What is the FDA product code for 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER?

The FDA product code for 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER 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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