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FDA 510(k)

COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A

K-Number: K904070 · 1992-10-09

ApplicantKretztechnik AG
Decision Date1992-10-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A is the device name listed in this FDA 510(k) record. The listed applicant is Kretztechnik AG. It received FDA 510(k) clearance on 1992-10-09 under 510(k) number K904070. 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) 330, MODEL # IR17.5AG/A & VRW177AK/A?

COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A is a medical device that received FDA 510(k) clearance on 1992-10-09. The listed applicant is Kretztechnik AG. The 510(k) number is K904070.

When did COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A receive FDA 510(k) clearance?

COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A received FDA 510(k) clearance on 1992-10-09, under 510(k) number K904070.

Who is the listed applicant for COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A?

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) 330, MODEL # IR17.5AG/A & VRW177AK/A?

The FDA product code for COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A 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.

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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.

K925354COMBISON(R) 311K910966SECTOR 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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