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510(k) K981745

BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX by Sunscope Intl., Inc. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1998
Date Received
May 18, 1998
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

Other clearances by Sunscope Intl., Inc.

  • K002786 — BIOSENSORS CENTRAL VENOUS CATHETER KITS (November 17, 2000)
  • K983372 — BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP (February 5, 1999)
  • K973477 — BIOSENSORS EMBOLECTOMY CATHETER (September 4, 1998)
  • K981747 — BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX (August 20, 1998)
  • K911710 — HEPARIN COATED THERMODILUTION CATH & ACCESSORIES (October 23, 1991)
  • K912172 — SAFEWEDGE(TM) RELIEF VALVE DEVICE (September 27, 1991)

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