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FDA 510(k)

COMBISON(R) 311

K-Number: K925354 · 1993-07-08

ApplicantKretztechnik AG
Decision Date1993-07-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMBISON(R) 311 is the device name listed in this FDA 510(k) record. The listed applicant is Kretztechnik AG. It received FDA 510(k) clearance on 1993-07-08 under 510(k) number K925354. 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 COMBISON(R) 311?

COMBISON(R) 311 is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Kretztechnik AG. The 510(k) number is K925354.

When did COMBISON(R) 311 receive FDA 510(k) clearance?

COMBISON(R) 311 received FDA 510(k) clearance on 1993-07-08, under 510(k) number K925354.

Who is the listed applicant for COMBISON(R) 311?

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

What is the FDA product code for COMBISON(R) 311?

The FDA product code for COMBISON(R) 311 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 Kretztechnik AG 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.

K904070COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/AK910966SECTOR TRANSDUCER MODEL NO. AWP3.5/AK904665MODEL IW17.5A INTRA OPERATIVE TRANSDUCERK901725ADD'L TRANSDUCER FOR USE W/THE COMBISON 310AK9016551 TRANSDUCER FOR COMBISON 310A

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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