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FDA 510(k)

HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2

K-Number: K850070 · 1985-01-22

ApplicantHealthcheck Corp.
Decision Date1985-01-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 is the device name listed in this FDA 510(k) record. The listed applicant is Healthcheck Corp.. It received FDA 510(k) clearance on 1985-01-22 under 510(k) number K850070. 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 HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2?

HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 is a medical device that received FDA 510(k) clearance on 1985-01-22. The listed applicant is Healthcheck Corp.. The 510(k) number is K850070.

When did HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 receive FDA 510(k) clearance?

HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 received FDA 510(k) clearance on 1985-01-22, under 510(k) number K850070.

Who is the listed applicant for HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2?

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

What is the FDA product code for HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2?

The FDA product code for HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 is DXN.

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Other records listing Healthcheck Corp. 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.

K884489C&T PREGNANCY TEST KITK874818TENSTARK881003DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1K863181HEALTHCHECK THERM-STRIPK861946PTK PLUS. HOME PREGNANCY TESTK860287PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3

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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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