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FDA 510(k)

MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK

K-Number: K900271 · 1990-04-19

ApplicantDigisonics, Inc.
Decision Date1990-04-19
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK is the device name listed in this FDA 510(k) record. The listed applicant is Digisonics, Inc.. It received FDA 510(k) clearance on 1990-04-19 under 510(k) number K900271. 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 MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK?

MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK is a medical device that received FDA 510(k) clearance on 1990-04-19. The listed applicant is Digisonics, Inc.. The 510(k) number is K900271.

When did MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK receive FDA 510(k) clearance?

MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK received FDA 510(k) clearance on 1990-04-19, under 510(k) number K900271.

Who is the listed applicant for MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK?

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

What is the FDA product code for MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK?

The FDA product code for MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK 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.

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Other records listing Digisonics, 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.

K970402DOCTORS REVIEW SYSTEMK800766ECHO-COMP

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.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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