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FDA 510(k)

CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM

K-Number: K861359 · 1986-05-16

ApplicantHewlett-Packard Co.
Decision Date1986-05-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM 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 1986-05-16 under 510(k) number K861359. 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 CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM?

CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K861359.

When did CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM receive FDA 510(k) clearance?

CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM received FDA 510(k) clearance on 1986-05-16, under 510(k) number K861359.

Who is the listed applicant for CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM?

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 CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM?

The FDA product code for CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM 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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