Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DYNAPULSE 5000A (DP5000A)

K-Number: K945111 · 1995-06-23

ApplicantPulse Metric, Inc.
Decision Date1995-06-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DYNAPULSE 5000A (DP5000A) 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 1995-06-23 under 510(k) number K945111. 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 5000A (DP5000A)?

DYNAPULSE 5000A (DP5000A) is a medical device that received FDA 510(k) clearance on 1995-06-23. The listed applicant is Pulse Metric, Inc.. The 510(k) number is K945111.

When did DYNAPULSE 5000A (DP5000A) receive FDA 510(k) clearance?

DYNAPULSE 5000A (DP5000A) received FDA 510(k) clearance on 1995-06-23, under 510(k) number K945111.

Who is the listed applicant for DYNAPULSE 5000A (DP5000A)?

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 5000A (DP5000A)?

The FDA product code for DYNAPULSE 5000A (DP5000A) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK012498DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEMK904739DYNAPULSE 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

View on FDA Database →

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

↑