FDA 510(k)

AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P

K-Number: K003711 · 2000-12-15

Decision Date2000-12-15

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P 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 2000-12-15 under 510(k) number K003711. 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 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P?

AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Sein Electronics Co., Ltd.. The 510(k) number is K003711.

When did AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P receive FDA 510(k) clearance?

AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003711.

Who is the listed applicant for AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P?

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 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P?

The FDA product code for AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P is DXN.

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

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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

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