FDA 510(k)

COMBISON 530D WITH POWER DOPPLER MODE

K-Number: K974813 · 1998-09-29

Decision Date1998-09-29

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

COMBISON 530D WITH POWER DOPPLER MODE is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 1998-09-29 under 510(k) number K974813. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBISON 530D WITH POWER DOPPLER MODE?

COMBISON 530D WITH POWER DOPPLER MODE is a medical device that received FDA 510(k) clearance on 1998-09-29. The listed applicant is Medison America, Inc.. The 510(k) number is K974813.

When did COMBISON 530D WITH POWER DOPPLER MODE receive FDA 510(k) clearance?

COMBISON 530D WITH POWER DOPPLER MODE received FDA 510(k) clearance on 1998-09-29, under 510(k) number K974813.

Who is the listed applicant for COMBISON 530D WITH POWER DOPPLER MODE?

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

What is the FDA product code for COMBISON 530D WITH POWER DOPPLER MODE?

The FDA product code for COMBISON 530D WITH POWER DOPPLER MODE is IYN.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medison America, Inc. as applicant

K032329SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM K031552MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS K013627SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM K012887SA6000II DIAGNOSTIC ULTRASOUND SYSTEM K012867SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM K003525VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM

View all 21 devices →

Related Devices (Code: IYN)

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.