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FDA 510(k)

REAL TIME OBSTETRICAL ULTRASONIC SCANNER

K-Number: K761052 · 1976-12-16

ApplicantSmithkline Diagnostics, Inc.
Decision Date1976-12-16
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

REAL TIME OBSTETRICAL ULTRASONIC SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1976-12-16 under 510(k) number K761052. The device is classified under product code HEM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL TIME OBSTETRICAL ULTRASONIC SCANNER?

REAL TIME OBSTETRICAL ULTRASONIC SCANNER is a medical device that received FDA 510(k) clearance on 1976-12-16. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K761052.

When did REAL TIME OBSTETRICAL ULTRASONIC SCANNER receive FDA 510(k) clearance?

REAL TIME OBSTETRICAL ULTRASONIC SCANNER received FDA 510(k) clearance on 1976-12-16, under 510(k) number K761052.

Who is the listed applicant for REAL TIME OBSTETRICAL ULTRASONIC SCANNER?

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

What is the FDA product code for REAL TIME OBSTETRICAL ULTRASONIC SCANNER?

The FDA product code for REAL TIME OBSTETRICAL ULTRASONIC SCANNER is HEM.

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Other records listing Smithkline Diagnostics, Inc. as applicant

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K961062FLEXSURE OBTK960183FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)K934863FLEXSURE HPK880499HEMOCCULT SENSITIVE TESTK875131(SKD) CHOLESTEROL TEST KITK862849HEMOCCULT WIPE TEST

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Related Devices (Code: HEM)

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.

K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology LabsK942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMedical Soft, Inc.K910426SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTShimadzu Medical SystemsK905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCorometrics Medical Systems, Inc.K900505SONOACE 88 PORTABLE ULTRASOUND SCANNERMedison Co., Ltd.K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, Inc.

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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