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FDA 510(k)

MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S

K-Number: K071645 · 2007-07-02

ApplicantOmron Healthcare, Inc.
Decision Date2007-07-02
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S 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 2007-07-02 under 510(k) number K071645. 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 MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S?

MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S is a medical device that received FDA 510(k) clearance on 2007-07-02. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K071645.

When did MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S receive FDA 510(k) clearance?

MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S received FDA 510(k) clearance on 2007-07-02, under 510(k) number K071645.

Who is the listed applicant for MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S?

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 MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S?

The FDA product code for MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S is MWI.

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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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