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FDA 510(k)

BOSCH BLOOD PRESSURE METER (BP5000 BT)

K-Number: K131026 · 2013-11-14

ApplicantRobert Bosch Healthcare Systems, Inc.
Decision Date2013-11-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOSCH BLOOD PRESSURE METER (BP5000 BT) is the device name listed in this FDA 510(k) record. The listed applicant is Robert Bosch Healthcare Systems, Inc.. It received FDA 510(k) clearance on 2013-11-14 under 510(k) number K131026. 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 BOSCH BLOOD PRESSURE METER (BP5000 BT)?

BOSCH BLOOD PRESSURE METER (BP5000 BT) is a medical device that received FDA 510(k) clearance on 2013-11-14. The listed applicant is Robert Bosch Healthcare Systems, Inc.. The 510(k) number is K131026.

When did BOSCH BLOOD PRESSURE METER (BP5000 BT) receive FDA 510(k) clearance?

BOSCH BLOOD PRESSURE METER (BP5000 BT) received FDA 510(k) clearance on 2013-11-14, under 510(k) number K131026.

Who is the listed applicant for BOSCH BLOOD PRESSURE METER (BP5000 BT)?

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

What is the FDA product code for BOSCH BLOOD PRESSURE METER (BP5000 BT)?

The FDA product code for BOSCH BLOOD PRESSURE METER (BP5000 BT) 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.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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