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FDA 510(k)

MODEL IW17.5A INTRA OPERATIVE TRANSDUCER

K-Number: K904665 · 1991-01-11

ApplicantKretztechnik AG
Decision Date1991-01-11
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL IW17.5A INTRA OPERATIVE TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Kretztechnik AG. It received FDA 510(k) clearance on 1991-01-11 under 510(k) number K904665. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL IW17.5A INTRA OPERATIVE TRANSDUCER?

MODEL IW17.5A INTRA OPERATIVE TRANSDUCER is a medical device that received FDA 510(k) clearance on 1991-01-11. The listed applicant is Kretztechnik AG. The 510(k) number is K904665.

When did MODEL IW17.5A INTRA OPERATIVE TRANSDUCER receive FDA 510(k) clearance?

MODEL IW17.5A INTRA OPERATIVE TRANSDUCER received FDA 510(k) clearance on 1991-01-11, under 510(k) number K904665.

Who is the listed applicant for MODEL IW17.5A INTRA OPERATIVE TRANSDUCER?

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 MODEL IW17.5A INTRA OPERATIVE TRANSDUCER?

The FDA product code for MODEL IW17.5A INTRA OPERATIVE TRANSDUCER is ITX.

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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) 311K904070COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/AK910966SECTOR TRANSDUCER MODEL NO. AWP3.5/AK901725ADD'L TRANSDUCER FOR USE W/THE COMBISON 310AK9016551 TRANSDUCER FOR COMBISON 310A

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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