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510(k) Data Aggregation
K Number
K222810Device Name
TD-7301 Peak Flow meter
Manufacturer
GOSTAR Co., Ltd.
Date Cleared
2023-12-19
(459 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
GOSTAR Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K221419Device Name
TD-5010 Lancing Device and TD-5084 Sterile Lancets
Manufacturer
GOSTAR Co., Ltd.
Date Cleared
2023-01-20
(249 days)
Product Code
QRL, QRK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
GOSTAR Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.
For use only on a single patient in a home setting.
Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Device Description
The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components:
(1)TD-5010 Lancing Device
(2) Alternative Site Testing (AST) Cap
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