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FDA 510(k)

BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND

K-Number: K942490 · 1995-02-15

ApplicantMedical Soft, Inc.
Decision Date1995-02-15
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Medical Soft, Inc.. It received FDA 510(k) clearance on 1995-02-15 under 510(k) number K942490. 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 BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND?

BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND is a medical device that received FDA 510(k) clearance on 1995-02-15. The listed applicant is Medical Soft, Inc.. The 510(k) number is K942490.

When did BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND receive FDA 510(k) clearance?

BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND received FDA 510(k) clearance on 1995-02-15, under 510(k) number K942490.

Who is the listed applicant for BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND?

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

What is the FDA product code for BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND?

The FDA product code for BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND 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.

K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology LabsK910426SDU 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

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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