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FDA 510(k)

DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM

K-Number: K012498 · 2001-11-01

ApplicantPulse Metric, Inc.
Decision Date2001-11-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DYNAPULSE 500G (DP500G) BLLOD 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 2001-11-01 under 510(k) number K012498. 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 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM?

DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-11-01. The listed applicant is Pulse Metric, Inc.. The 510(k) number is K012498.

When did DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM receive FDA 510(k) clearance?

DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM received FDA 510(k) clearance on 2001-11-01, under 510(k) number K012498.

Who is the listed applicant for DYNAPULSE 500G (DP500G) BLLOD 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 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM?

The FDA product code for DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM is DXN.

Related Clinical Trials

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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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.

K013478DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEMK013358DYNAPULSE 5000A MINI ABP BLOOD 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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