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FDA 510(k)

CARDIOSONIC ACOUSTIC AMPLIFIER

K-Number: K813510 · 1982-01-12

ApplicantSrs Co.
Decision Date1982-01-12
Product CodeLDE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSONIC ACOUSTIC AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Srs Co.. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813510. The device is classified under product code LDE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSONIC ACOUSTIC AMPLIFIER?

CARDIOSONIC ACOUSTIC AMPLIFIER is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Srs Co.. The 510(k) number is K813510.

When did CARDIOSONIC ACOUSTIC AMPLIFIER receive FDA 510(k) clearance?

CARDIOSONIC ACOUSTIC AMPLIFIER received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813510.

Who is the listed applicant for CARDIOSONIC ACOUSTIC AMPLIFIER?

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

What is the FDA product code for CARDIOSONIC ACOUSTIC AMPLIFIER?

The FDA product code for CARDIOSONIC ACOUSTIC AMPLIFIER is LDE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Srs Co. 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.

K823381PROFESSIONAL MARK I BIOFEEDBACK SYS

Related Devices (Code: LDE)

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.

K945082CYPRESS MEDICAL PRODUCTS STETHOSCOPECypress Medical Products, Ltd.K944337VARIOUS STETHOSCOPESRud Riester GmbH & CO KGK940578MANUAL STETOSCOPEBhs Intl., Inc.K935944PROSCOPES AND ADSCOPESAmerican Diagnostic Corp.K923327STETHOSCOPE COVERAnup Chakraborty Co.K924095TIMEOSCOPE AND FLEXISCOPEStethoscopes of America, 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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