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FDA 510(k)

THE 500 MONITOR SERIES

K-Number: K823052 · 1982-11-30

ApplicantVitatek
Decision Date1982-11-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE 500 MONITOR SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Vitatek. It received FDA 510(k) clearance on 1982-11-30 under 510(k) number K823052. 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 THE 500 MONITOR SERIES?

THE 500 MONITOR SERIES is a medical device that received FDA 510(k) clearance on 1982-11-30. The listed applicant is Vitatek. The 510(k) number is K823052.

When did THE 500 MONITOR SERIES receive FDA 510(k) clearance?

THE 500 MONITOR SERIES received FDA 510(k) clearance on 1982-11-30, under 510(k) number K823052.

Who is the listed applicant for THE 500 MONITOR SERIES?

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

What is the FDA product code for THE 500 MONITOR SERIES?

The FDA product code for THE 500 MONITOR SERIES 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 Vitatek 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.

K810755SQUINN VITATEK 500 SERIES PHYSIOL. MONI

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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