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FDA 510(k)

OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907

K-Number: K001848 · 2000-07-03

ApplicantOmron Healthcare, Inc.
Decision Date2000-07-03
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 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 2000-07-03 under 510(k) number K001848. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907?

OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 is a medical device that received FDA 510(k) clearance on 2000-07-03. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K001848.

When did OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 receive FDA 510(k) clearance?

OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 received FDA 510(k) clearance on 2000-07-03, under 510(k) number K001848.

Who is the listed applicant for OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907?

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 OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907?

The FDA product code for OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 is DXN.

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Related Devices (Code: DXN)

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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