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FDA 510(k)

PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801

K-Number: K060766 · 2006-06-09

ApplicantOmron Healthcare, Inc.
Decision Date2006-06-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2006-06-09 under 510(k) number K060766. 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 PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801?

PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 is a medical device that received FDA 510(k) clearance on 2006-06-09. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K060766.

When did PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 receive FDA 510(k) clearance?

PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 received FDA 510(k) clearance on 2006-06-09, under 510(k) number K060766.

Who is the listed applicant for PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801?

The FDA product code for PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 is DPS.

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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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