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FDA 510(k)

ULTRASOUND B-SCANNING SYSTEM

K-Number: K770644 · 1977-04-14

ApplicantUnirad Corp.
Decision Date1977-04-14
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND B-SCANNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Unirad Corp.. It received FDA 510(k) clearance on 1977-04-14 under 510(k) number K770644. 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 ULTRASOUND B-SCANNING SYSTEM?

ULTRASOUND B-SCANNING SYSTEM is a medical device that received FDA 510(k) clearance on 1977-04-14. The listed applicant is Unirad Corp.. The 510(k) number is K770644.

When did ULTRASOUND B-SCANNING SYSTEM receive FDA 510(k) clearance?

ULTRASOUND B-SCANNING SYSTEM received FDA 510(k) clearance on 1977-04-14, under 510(k) number K770644.

Who is the listed applicant for ULTRASOUND B-SCANNING SYSTEM?

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

What is the FDA product code for ULTRASOUND B-SCANNING SYSTEM?

The FDA product code for ULTRASOUND B-SCANNING SYSTEM 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 Unirad Corp. 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.

K801655AUTO SECTOR SCANNERK801656EDP 1200 SECTOR SCANNER OPTIONK792638HIGH RESOLUTION IMAGING SYSTEM

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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