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FDA 510(k)

OB ULTRASOUND LINEAR SCANNER 630

K-Number: K842261 · 1984-09-19

ApplicantGe Medical Systems Information Technologies
Decision Date1984-09-19
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OB ULTRASOUND LINEAR SCANNER 630 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 1984-09-19 under 510(k) number K842261. 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 OB ULTRASOUND LINEAR SCANNER 630?

OB ULTRASOUND LINEAR SCANNER 630 is a medical device that received FDA 510(k) clearance on 1984-09-19. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K842261.

When did OB ULTRASOUND LINEAR SCANNER 630 receive FDA 510(k) clearance?

OB ULTRASOUND LINEAR SCANNER 630 received FDA 510(k) clearance on 1984-09-19, under 510(k) number K842261.

Who is the listed applicant for OB ULTRASOUND LINEAR SCANNER 630?

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 OB ULTRASOUND LINEAR SCANNER 630?

The FDA product code for OB ULTRASOUND LINEAR SCANNER 630 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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