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FDA 510(k)

OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C

K-Number: K903133 · 1991-01-18

ApplicantOmron Marshall Products, Inc.
Decision Date1991-01-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C is the device name listed in this FDA 510(k) record. The listed applicant is Omron Marshall Products, Inc.. It received FDA 510(k) clearance on 1991-01-18 under 510(k) number K903133. 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 OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C?

OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is Omron Marshall Products, Inc.. The 510(k) number is K903133.

When did OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C receive FDA 510(k) clearance?

OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C received FDA 510(k) clearance on 1991-01-18, under 510(k) number K903133.

Who is the listed applicant for OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C?

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

What is the FDA product code for OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C?

The FDA product code for OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C 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.

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Other records listing Omron Marshall Products, 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.

K903134OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705CK901963OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02

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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