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)

BP50 BLOOD PRESSURE AND PULSE MONITOR

K-Number: K901392 · 1990-08-23

ApplicantPulse Time Products, Ltd.
Decision Date1990-08-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BP50 BLOOD PRESSURE AND PULSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Time Products, Ltd.. It received FDA 510(k) clearance on 1990-08-23 under 510(k) number K901392. 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 BP50 BLOOD PRESSURE AND PULSE MONITOR?

BP50 BLOOD PRESSURE AND PULSE MONITOR is a medical device that received FDA 510(k) clearance on 1990-08-23. The listed applicant is Pulse Time Products, Ltd.. The 510(k) number is K901392.

When did BP50 BLOOD PRESSURE AND PULSE MONITOR receive FDA 510(k) clearance?

BP50 BLOOD PRESSURE AND PULSE MONITOR received FDA 510(k) clearance on 1990-08-23, under 510(k) number K901392.

Who is the listed applicant for BP50 BLOOD PRESSURE AND PULSE MONITOR?

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

What is the FDA product code for BP50 BLOOD PRESSURE AND PULSE MONITOR?

The FDA product code for BP50 BLOOD PRESSURE AND PULSE MONITOR 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 Time Products, Ltd. 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.

K892795PULSE TIME PRODUCTS LIMITED, PM-3K892794PULSE TIME PRODUCTS LIMITED, PM-2K864411PULSE/B.P. MONITORK864748PM-8 HEART RATE MONITORK811425CARDIACMONITORS

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.

↑