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510(k) K842194

PRESSURE MONITOR by Norton Texas Medical Products — Product Code DXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
June 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4310
Review Panel
CV
Submission Type

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  • K852232 — PRESSURE DISPLAY BOX #60000/TUBING SET #61000 (August 9, 1985)
  • K831750 — PM-3 (July 26, 1983)
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  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)