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510(k) K960916

SAMS 8000 CARDIOPLEGIA MONITOR by 3M Health Care, Sarns — Product Code DSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1996
Date Received
March 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Blood-Pressure
Device Class
Class II
Regulation Number
870.1100
Review Panel
CV
Submission Type

Other clearances by 3M Health Care, Sarns

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  • K950739 — 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTE (November 17, 1995)
  • K941653 — SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION (August 24, 1994)
  • K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION (July 26, 1994)
  • K940651 — SARNS ULTRASONIC AIR SENSOR (May 24, 1994)
  • K935391 — SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PA (February 24, 1994)
  • K934127 — SARNS LOW JETTING AORTIC ARCH CANNULA (February 22, 1994)
  • K935977 — SARNS AIR DETECTION SYSTEM (February 4, 1994)
  • K915547 — SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT (September 9, 1993)
  • K925076 — SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. (June 7, 1993)

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  • K133961 — SURESIGNS VS3, SURESIGNS VS4 (June 26, 2014)
  • K910262 — KELLER VITAL SIGNS MONITOR - KMS-890 (April 1, 1991)