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FDA 510(k)

OMRON MODEL HBP-2070 VITAL SIGNS MONITOR

K-Number: K082812 · 2008-10-22

ApplicantOmron Healthcare, Inc.
Decision Date2008-10-22
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMRON MODEL HBP-2070 VITAL SIGNS MONITOR 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 2008-10-22 under 510(k) number K082812. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMRON MODEL HBP-2070 VITAL SIGNS MONITOR?

OMRON MODEL HBP-2070 VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 2008-10-22. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K082812.

When did OMRON MODEL HBP-2070 VITAL SIGNS MONITOR receive FDA 510(k) clearance?

OMRON MODEL HBP-2070 VITAL SIGNS MONITOR received FDA 510(k) clearance on 2008-10-22, under 510(k) number K082812.

Who is the listed applicant for OMRON MODEL HBP-2070 VITAL SIGNS MONITOR?

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 MODEL HBP-2070 VITAL SIGNS MONITOR?

The FDA product code for OMRON MODEL HBP-2070 VITAL SIGNS MONITOR is MWI.

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Related Devices (Code: MWI)

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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