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510(k) K842194

PRESSURE MONITOR by Norton Texas Medical Products — Product Code DXS

K842194 is an FDA 510(k) premarket notification submitted by Norton Texas Medical Products for the device "PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4310. Norton Texas Medical Products has at least 3 other 510(k) clearances on record.

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

Other clearances by Norton Texas Medical Products

  • K843983 — MYOCARDIAL INSULATOR (December 27, 1984)
  • K842992 — GRASSHOPPER - RETRACTOR (August 17, 1984)
  • K832517 — CUSTOM KWIK SET AND/OR PAK (October 14, 1983)

Other clearances for product code DXS

  • K113235 — PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS (December 2, 2011)
  • K944764 — VTI DISPOSABLE PRESSURE DISPLAY SET (December 27, 1994)
  • K912045 — TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (October 31, 1991)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)
  • K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-3 (November 6, 1987)
  • K862836 — STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE (September 12, 1986)
  • K852232 — PRESSURE DISPLAY BOX #60000/TUBING SET #61000 (August 9, 1985)
  • K831750 — PM-3 (July 26, 1983)
  • K822822 — GAMBRO PRESSURE MONITOR PRM 10 (October 18, 1982)
  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)

FDA data resources