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FDA 510(k)

DIASONICS ITNRAOPERATIVE PROBES

K-Number: K961002 · 1997-01-22

ApplicantDiasonics Ultrasound
Decision Date1997-01-22
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIASONICS ITNRAOPERATIVE PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics Ultrasound. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K961002. 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 DIASONICS ITNRAOPERATIVE PROBES?

DIASONICS ITNRAOPERATIVE PROBES is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Diasonics Ultrasound. The 510(k) number is K961002.

When did DIASONICS ITNRAOPERATIVE PROBES receive FDA 510(k) clearance?

DIASONICS ITNRAOPERATIVE PROBES received FDA 510(k) clearance on 1997-01-22, under 510(k) number K961002.

Who is the listed applicant for DIASONICS ITNRAOPERATIVE PROBES?

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

What is the FDA product code for DIASONICS ITNRAOPERATIVE PROBES?

The FDA product code for DIASONICS ITNRAOPERATIVE PROBES is ITX.

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 Diasonics Ultrasound 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.

K951998DIASONICS MASTERS SERIES 5000 ULTRASOUND SCANNER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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