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FDA 510(k)

SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS

K-Number: K921863 · 1992-09-28

ApplicantHewlett-Packard Co.
Decision Date1992-09-28
Product CodeGXW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS 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 1992-09-28 under 510(k) number K921863. The device is classified under product code GXW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS?

SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS is a medical device that received FDA 510(k) clearance on 1992-09-28. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K921863.

When did SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS receive FDA 510(k) clearance?

SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS received FDA 510(k) clearance on 1992-09-28, under 510(k) number K921863.

Who is the listed applicant for SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS?

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 SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS?

The FDA product code for SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS is GXW.

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Other records listing Hewlett-Packard Co. 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.

K992543HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLEK993587HP M2376A DEVICE LINK SYSTEMK993169MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810AK992977HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504AK993516HP M2600A VIRIDIA TELEMETRY SYSTEMK993171HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A

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Related Devices (Code: GXW)

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.

K903085SMS-712NAToshiba America Medical Systems, In.CK8534325.0 IOP & 7.5 IOP PROBESDiasonics, Inc.K833522NEURO SECTOR FIXATION DEVICEAdvanced Technology Laboratories, Inc.K821736ECHO-PULSE KM555Rabar, Inc.K770788ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000Storz Instrument Co.K770575ECHOENCEPHALOGRAPH, DIGITAL, 1000Storz Instrument Co.

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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