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FDA 510(k)

HP CATHSTATION - MODEL M1264B

K-Number: K961401 · 1996-10-08

ApplicantHewlett-Packard Co.
Decision Date1996-10-08
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HP CATHSTATION - MODEL M1264B 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 1996-10-08 under 510(k) number K961401. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HP CATHSTATION - MODEL M1264B?

HP CATHSTATION - MODEL M1264B is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K961401.

When did HP CATHSTATION - MODEL M1264B receive FDA 510(k) clearance?

HP CATHSTATION - MODEL M1264B received FDA 510(k) clearance on 1996-10-08, under 510(k) number K961401.

Who is the listed applicant for HP CATHSTATION - MODEL M1264B?

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 CATHSTATION - MODEL M1264B?

The FDA product code for HP CATHSTATION - MODEL M1264B is DPS.

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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: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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