Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER

K-Number: K881723 · 1988-08-12

ApplicantBiosound, Inc.
Decision Date1988-08-12
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K881723. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER?

GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is Biosound, Inc.. The 510(k) number is K881723.

When did GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER receive FDA 510(k) clearance?

GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER received FDA 510(k) clearance on 1988-08-12, under 510(k) number K881723.

Who is the listed applicant for GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER?

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

What is the FDA product code for GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER?

The FDA product code for GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER is JOP.

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 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

View all 39 devices →

Related Devices (Code: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

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.

↑