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FDA 510(k)

DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM

K-Number: K013478 · 2002-01-10

ApplicantPulse Metric, Inc.
Decision Date2002-01-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Metric, Inc.. It received FDA 510(k) clearance on 2002-01-10 under 510(k) number K013478. 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 DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM?

DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-10. The listed applicant is Pulse Metric, Inc.. The 510(k) number is K013478.

When did DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM receive FDA 510(k) clearance?

DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM received FDA 510(k) clearance on 2002-01-10, under 510(k) number K013478.

Who is the listed applicant for DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM?

The FDA 510(k) record lists Pulse Metric, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM?

The FDA product code for DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM is DXN.

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Other records listing Pulse Metric, Inc. as applicant

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.

K013358DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEMK012498DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEMK945111DYNAPULSE 5000A (DP5000A)K904739DYNAPULSE 200M

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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