Home / 510(k) Clearances / K151040

510(k) K151040

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 by Biometrix , Ltd. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2015
Date Received
April 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type

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  • K925040 — TELEPULSE (August 23, 1993)

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