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FDA 510(k)

645OB SECTOR/LINEAR ULTRASOUND SCANNER

K-Number: K861931 · 1986-07-31

ApplicantGe Medical Systems Information Technologies
Decision Date1986-07-31
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent for Some Indications

Device Summary

645OB SECTOR/LINEAR ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1986-07-31 under 510(k) number K861931. The device is classified under product code HEM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the 645OB SECTOR/LINEAR ULTRASOUND SCANNER?

645OB SECTOR/LINEAR ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K861931.

When did 645OB SECTOR/LINEAR ULTRASOUND SCANNER receive FDA 510(k) clearance?

645OB SECTOR/LINEAR ULTRASOUND SCANNER received FDA 510(k) clearance on 1986-07-31, under 510(k) number K861931.

Who is the listed applicant for 645OB SECTOR/LINEAR ULTRASOUND SCANNER?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 645OB SECTOR/LINEAR ULTRASOUND SCANNER?

The FDA product code for 645OB SECTOR/LINEAR ULTRASOUND SCANNER is HEM.

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Other records listing Ge Medical Systems Information Technologies 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.

K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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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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