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FDA 510(k)

M1765A ECG MANAGER

K-Number: K974746 · 1998-03-18

ApplicantHewlett-Packard Co.
Decision Date1998-03-18
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M1765A ECG MANAGER 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 1998-03-18 under 510(k) number K974746. 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 M1765A ECG MANAGER?

M1765A ECG MANAGER is a medical device that received FDA 510(k) clearance on 1998-03-18. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K974746.

When did M1765A ECG MANAGER receive FDA 510(k) clearance?

M1765A ECG MANAGER received FDA 510(k) clearance on 1998-03-18, under 510(k) number K974746.

Who is the listed applicant for M1765A ECG MANAGER?

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 M1765A ECG MANAGER?

The FDA product code for M1765A ECG MANAGER 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.

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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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