FDA 510(k)

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series

Numéro K : K163113 · 2017-01-19

DemandeurGrandway Technology (Shenzhen) Limited

Date de décision2017-01-19

Code produitDXN

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K163113. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series?

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K163113.

When did Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series receive FDA 510(k) clearance?

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series received FDA 510(k) clearance on 2017-01-19, under 510(k) number K163113.

Who is the listed applicant for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series?

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

What is the FDA product code for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series?

The FDA product code for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is DXN.

Essais cliniques associés

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Autres dossiers indiquant Grandway Technology (Shenzhen) Limited en tant que demandeur

K191593Digital Automatic Blood Pressure Monitor MD36 Series K171379Digital Automatic Wrist Blood Pressure Monitor MD4300 K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series K163679Digital Automatic Blood Pressure Monitor MD3600

Dispositifs connexes (Code : DXN)

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.

Source officielle

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