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FDA 510(k)

ABACUS OB ULTRASOUNG COMPUTER SOFTWARE

K-Number: K951393 · 1995-05-01

ApplicantSolomon Technology Labs
Decision Date1995-05-01
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ABACUS OB ULTRASOUNG COMPUTER SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Solomon Technology Labs. It received FDA 510(k) clearance on 1995-05-01 under 510(k) number K951393. 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 ABACUS OB ULTRASOUNG COMPUTER SOFTWARE?

ABACUS OB ULTRASOUNG COMPUTER SOFTWARE is a medical device that received FDA 510(k) clearance on 1995-05-01. The listed applicant is Solomon Technology Labs. The 510(k) number is K951393.

When did ABACUS OB ULTRASOUNG COMPUTER SOFTWARE receive FDA 510(k) clearance?

ABACUS OB ULTRASOUNG COMPUTER SOFTWARE received FDA 510(k) clearance on 1995-05-01, under 510(k) number K951393.

Who is the listed applicant for ABACUS OB ULTRASOUNG COMPUTER SOFTWARE?

The FDA 510(k) record lists Solomon Technology Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABACUS OB ULTRASOUNG COMPUTER SOFTWARE?

The FDA product code for ABACUS OB ULTRASOUNG COMPUTER SOFTWARE is HEM.

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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.

K942490BABE 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.K890637EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGEElscint, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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