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FDA 510(k)

HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115

K-Number: K852653 · 1985-12-30

ApplicantHealthteam
Decision Date1985-12-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 is the device name listed in this FDA 510(k) record. The listed applicant is Healthteam. It received FDA 510(k) clearance on 1985-12-30 under 510(k) number K852653. 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 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115?

HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 is a medical device that received FDA 510(k) clearance on 1985-12-30. The listed applicant is Healthteam. The 510(k) number is K852653.

When did HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 receive FDA 510(k) clearance?

HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 received FDA 510(k) clearance on 1985-12-30, under 510(k) number K852653.

Who is the listed applicant for HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115?

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

What is the FDA product code for HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115?

The FDA product code for HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 is DXN.

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Other records listing Healthteam 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.

K890585INFRARED HEXK890586INFRARED DELUXEK890588GENTLE EXPRESSIONS ELECTRIC BREAST PUMPK852459HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175K852458HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145K852457HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165

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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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