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FDA 510(k)

BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM

K-Number: K051368 · 2005-08-09

ApplicantSchiller AG
Decision Date2005-08-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2005-08-09 under 510(k) number K051368. 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 BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM?

BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-09. The listed applicant is Schiller AG. The 510(k) number is K051368.

When did BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM receive FDA 510(k) clearance?

BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM received FDA 510(k) clearance on 2005-08-09, under 510(k) number K051368.

Who is the listed applicant for BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM?

The FDA 510(k) record lists Schiller AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM?

The FDA product code for BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM is DXN.

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Other records listing Schiller AG as applicant

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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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

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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