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FDA 510(k)

TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM

K-Number: K121141 · 2012-05-15

ApplicantTensys Medical Systems, Inc.
Decision Date2012-05-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tensys Medical Systems, Inc.. It received FDA 510(k) clearance on 2012-05-15 under 510(k) number K121141. 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 TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM?

TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-15. The listed applicant is Tensys Medical Systems, Inc.. The 510(k) number is K121141.

When did TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM receive FDA 510(k) clearance?

TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM received FDA 510(k) clearance on 2012-05-15, under 510(k) number K121141.

Who is the listed applicant for TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM?

The FDA 510(k) record lists Tensys Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM?

The FDA product code for TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM is DXN.

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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

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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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