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FDA 510(k)

ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630

K-Number: K001671 · 2000-06-30

ApplicantOmron Healthcare, Inc.
Decision Date2000-06-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K001671. 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 ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630?

ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K001671.

When did ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 receive FDA 510(k) clearance?

ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001671.

Who is the listed applicant for ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630?

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

What is the FDA product code for ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630?

The FDA product code for ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 is DXN.

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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.

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