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FDA 510(k)

5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU

K-Number: K910669 · 1991-03-15

ApplicantSiemens Ultrasound, Inc.
Decision Date1991-03-15
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Ultrasound, Inc.. It received FDA 510(k) clearance on 1991-03-15 under 510(k) number K910669. 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 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU?

5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU is a medical device that received FDA 510(k) clearance on 1991-03-15. The listed applicant is Siemens Ultrasound, Inc.. The 510(k) number is K910669.

When did 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU receive FDA 510(k) clearance?

5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU received FDA 510(k) clearance on 1991-03-15, under 510(k) number K910669.

Who is the listed applicant for 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU?

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

What is the FDA product code for 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU?

The FDA product code for 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU is ITX.

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Other records listing Siemens Ultrasound, Inc. 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.

K914013SIEMENS SI-400K912361SI-450/ILUS (INTRALUMINAL ULTRASOUND)K911200SI-1200 / ILUSK904017SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICESK9105297.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANSK891449SONOLINE CF

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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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