FDA 510(k)

FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H

K-Number: K003282 · 2000-11-01

Decision Date2000-11-01

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H is the device name listed in this FDA 510(k) record. The listed applicant is Sein Electronics Co., Ltd.. It received FDA 510(k) clearance on 2000-11-01 under 510(k) number K003282. 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 FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H?

FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H is a medical device that received FDA 510(k) clearance on 2000-11-01. The listed applicant is Sein Electronics Co., Ltd.. The 510(k) number is K003282.

When did FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H receive FDA 510(k) clearance?

FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H received FDA 510(k) clearance on 2000-11-01, under 510(k) number K003282.

Who is the listed applicant for FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H?

The FDA 510(k) record lists Sein Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H?

The FDA product code for FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sein Electronics Co., Ltd. as applicant

K052108SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 K042138FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 K042014DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 K032927FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR K012054FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 K003711AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P

View all 12 devices →

Related Devices (Code: DXN)

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.