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FDA 510(k)

OBSTETRICAL ULTRASOUND COMPUTER

K-Number: K840623 · 1984-05-11

ApplicantR & S Systems
Decision Date1984-05-11
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OBSTETRICAL ULTRASOUND COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is R & S Systems. It received FDA 510(k) clearance on 1984-05-11 under 510(k) number K840623. 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 OBSTETRICAL ULTRASOUND COMPUTER?

OBSTETRICAL ULTRASOUND COMPUTER is a medical device that received FDA 510(k) clearance on 1984-05-11. The listed applicant is R & S Systems. The 510(k) number is K840623.

When did OBSTETRICAL ULTRASOUND COMPUTER receive FDA 510(k) clearance?

OBSTETRICAL ULTRASOUND COMPUTER received FDA 510(k) clearance on 1984-05-11, under 510(k) number K840623.

Who is the listed applicant for OBSTETRICAL ULTRASOUND COMPUTER?

The FDA 510(k) record lists R & S Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBSTETRICAL ULTRASOUND COMPUTER?

The FDA product code for OBSTETRICAL ULTRASOUND COMPUTER is HEM.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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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