Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer

FDA 510(k) K151040 · Biometrix , Ltd.

Substantially Equivalent

510(k) numberK151040

Submission

Device name
Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
Applicant
Biometrix , Ltd.
Jerusalem, IL
Received
April 20, 2015
Decision date
September 4, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRS – Transducer, Blood-Pressure, Extravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2850
Specialty
Cardiovascular

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Questions and answers

When was Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer cleared by the FDA?

Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer (K151040) received a 510(k) decision of Substantially Equivalent on September 4, 2015, 137 days after the submission was received.

What is the product code of K151040?

The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.