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FDA 510(k)

ELECTRONIC DIGITAL SPHYGMOMANOMETER

K-Number: K820300 · 1982-03-25

ApplicantCopal, Inc.
Decision Date1982-03-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC DIGITAL SPHYGMOMANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Copal, Inc.. It received FDA 510(k) clearance on 1982-03-25 under 510(k) number K820300. 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 ELECTRONIC DIGITAL SPHYGMOMANOMETER?

ELECTRONIC DIGITAL SPHYGMOMANOMETER is a medical device that received FDA 510(k) clearance on 1982-03-25. The listed applicant is Copal, Inc.. The 510(k) number is K820300.

When did ELECTRONIC DIGITAL SPHYGMOMANOMETER receive FDA 510(k) clearance?

ELECTRONIC DIGITAL SPHYGMOMANOMETER received FDA 510(k) clearance on 1982-03-25, under 510(k) number K820300.

Who is the listed applicant for ELECTRONIC DIGITAL SPHYGMOMANOMETER?

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

What is the FDA product code for ELECTRONIC DIGITAL SPHYGMOMANOMETER?

The FDA product code for ELECTRONIC DIGITAL SPHYGMOMANOMETER 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 Copal, 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.

K832721DIGITAL SPHYGMOMANOMETER UA-231K832722DIGITAL SPHYGMOMANOMETER UA-251K832723DIGITAL SPHGMOMANOMETER UA-271K832724ACTIMETER UB-103

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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