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FDA 510(k)

ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.

K-Number: K872265 · 1988-01-04

ApplicantLabsonics, Inc.
Decision Date1988-01-04
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. is the device name listed in this FDA 510(k) record. The listed applicant is Labsonics, Inc.. It received FDA 510(k) clearance on 1988-01-04 under 510(k) number K872265. 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 ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.?

ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. is a medical device that received FDA 510(k) clearance on 1988-01-04. The listed applicant is Labsonics, Inc.. The 510(k) number is K872265.

When did ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. receive FDA 510(k) clearance?

ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. received FDA 510(k) clearance on 1988-01-04, under 510(k) number K872265.

Who is the listed applicant for ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.?

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

What is the FDA product code for ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.?

The FDA product code for ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. is HGL.

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.

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Other records listing Labsonics, 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.

K874854GPS/WGPS/PREVIEW GP

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 AmericaK903316ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERGe Medical Systems Information Technologies

Official Source

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