Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UFIT TEN-10

K-Number: K122443 · 2012-11-20

ApplicantBiosign Technologies, Inc.
Decision Date2012-11-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UFIT TEN-10 is the device name listed in this FDA 510(k) record. The listed applicant is Biosign Technologies, Inc.. It received FDA 510(k) clearance on 2012-11-20 under 510(k) number K122443. 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 UFIT TEN-10?

UFIT TEN-10 is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Biosign Technologies, Inc.. The 510(k) number is K122443.

When did UFIT TEN-10 receive FDA 510(k) clearance?

UFIT TEN-10 received FDA 510(k) clearance on 2012-11-20, under 510(k) number K122443.

Who is the listed applicant for UFIT TEN-10?

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

What is the FDA product code for UFIT TEN-10?

The FDA product code for UFIT TEN-10 is DXN.

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.

↑