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FDA 510(k)

BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM

K-Number: K837063 · 1983-04-04

ApplicantBiosound, Inc.
Decision Date1983-04-04
Product Code
DecisionSubstantially Equivalent

Device Summary

BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1983-04-04 under 510(k) number K837063. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM?

BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1983-04-04. The listed applicant is Biosound, Inc.. The 510(k) number is K837063.

When did BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1983-04-04, under 510(k) number K837063.

Who is the listed applicant for BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM?

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

Related Clinical Trials

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Other records listing Biosound, 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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963936ACCESSPOINT, MED E-MAIL, DICOM READERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

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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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