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FDA 510(k)

EXTENDED MULTIPURPOSE TRANSDUCER RANGE

K-Number: K880580 · 1988-06-08

ApplicantPie Medical USA BV
Decision Date1988-06-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXTENDED MULTIPURPOSE TRANSDUCER RANGE is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical USA BV. It received FDA 510(k) clearance on 1988-06-08 under 510(k) number K880580. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTENDED MULTIPURPOSE TRANSDUCER RANGE?

EXTENDED MULTIPURPOSE TRANSDUCER RANGE is a medical device that received FDA 510(k) clearance on 1988-06-08. The listed applicant is Pie Medical USA BV. The 510(k) number is K880580.

When did EXTENDED MULTIPURPOSE TRANSDUCER RANGE receive FDA 510(k) clearance?

EXTENDED MULTIPURPOSE TRANSDUCER RANGE received FDA 510(k) clearance on 1988-06-08, under 510(k) number K880580.

Who is the listed applicant for EXTENDED MULTIPURPOSE TRANSDUCER RANGE?

The FDA 510(k) record lists Pie Medical USA BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTENDED MULTIPURPOSE TRANSDUCER RANGE?

The FDA product code for EXTENDED MULTIPURPOSE TRANSDUCER RANGE is IYO.

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 Pie Medical USA BV 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.

K900469ULTRASOUND SCANNER MODEL #1150

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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