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FDA 510(k)

HP STAR ST AND ARRHHYTHMIA SOFTWARE

K-Number: K964122 · 1997-01-08

ApplicantHewlett-Packard Co.
Decision Date1997-01-08
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HP STAR ST AND ARRHHYTHMIA SOFTWARE 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 1997-01-08 under 510(k) number K964122. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HP STAR ST AND ARRHHYTHMIA SOFTWARE?

HP STAR ST AND ARRHHYTHMIA SOFTWARE is a medical device that received FDA 510(k) clearance on 1997-01-08. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K964122.

When did HP STAR ST AND ARRHHYTHMIA SOFTWARE receive FDA 510(k) clearance?

HP STAR ST AND ARRHHYTHMIA SOFTWARE received FDA 510(k) clearance on 1997-01-08, under 510(k) number K964122.

Who is the listed applicant for HP STAR ST AND ARRHHYTHMIA SOFTWARE?

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 HP STAR ST AND ARRHHYTHMIA SOFTWARE?

The FDA product code for HP STAR ST AND ARRHHYTHMIA SOFTWARE is DSI.

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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: DSI)

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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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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