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FDA 510(k)

EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE

K-Number: K890637 · 1989-06-12

ApplicantElscint, Inc.
Decision Date1989-06-12
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K890637. 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 EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE?

EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Elscint, Inc.. The 510(k) number is K890637.

When did EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE receive FDA 510(k) clearance?

EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE received FDA 510(k) clearance on 1989-06-12, under 510(k) number K890637.

Who is the listed applicant for EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE?

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

What is the FDA product code for EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE?

The FDA product code for EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE is HEM.

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Other records listing Elscint, 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.

K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORYK982060VOLUMAX CT IMAGING SYSTEMK974344CT SCOPEK980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EPK974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

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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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