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FDA 510(k)

SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM

K-Number: K970034 · 1997-03-17

ApplicantHewlett-Packard Co.
Decision Date1997-03-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1997-03-17 under 510(k) number K970034. 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 SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM?

SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K970034.

When did SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1997-03-17, under 510(k) number K970034.

Who is the listed applicant for SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM?

The FDA product code for SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM is ITX.

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Other records listing Hewlett-Packard Co. as applicant

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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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