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FDA 510(k)

BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7

K-Number: K050680 · 2005-05-13

ApplicantOSTAR MEDITECH CORP.
Decision Date2005-05-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 is the device name listed in this FDA 510(k) record. The listed applicant is OSTAR MEDITECH CORP.. It received FDA 510(k) clearance on 2005-05-13 under 510(k) number K050680. 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 BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7?

BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 is a medical device that received FDA 510(k) clearance on 2005-05-13. The listed applicant is OSTAR MEDITECH CORP.. The 510(k) number is K050680.

When did BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 receive FDA 510(k) clearance?

BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 received FDA 510(k) clearance on 2005-05-13, under 510(k) number K050680.

Who is the listed applicant for BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7?

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

What is the FDA product code for BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7?

The FDA product code for BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 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 OSTAR MEDITECH 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.

K112269OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE

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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