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510(k) K902492

CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S by Datex Division Instrumentarium Corp. — Product Code DRI

K902492 is an FDA 510(k) premarket notification submitted by Datex Division Instrumentarium Corp. for the device "CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S". The FDA issued a decision of Substantially Equivalent on July 6, 1990. The device falls under product code DRI (Monitor, Line Isolation), a Class I device regulated under 21 CFR 870.2620. Datex Division Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1990
Date Received
June 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Line Isolation
Device Class
Class I
Regulation Number
870.2620
Review Panel
CV
Submission Type

Other clearances by Datex Division Instrumentarium Corp.

  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)
  • K961247 — AS/3 LIGHT MONITOR (October 23, 1996)
  • K943458 — AS/3 AIRWAY MODULE (February 14, 1995)
  • K945234 — AS/3 MEMORY MODULE, M0MEM (January 27, 1995)
  • K933156 — DATEX AS/3 PATIENT MONITOR (December 30, 1994)
  • K933285 — DATEX AS/3 TM ANAESTHESIA MONITOR (November 14, 1994)
  • K943456 — AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT (October 17, 1994)
  • K923172 — ANAESTHESIA RECORD KEEPER (August 9, 1994)
  • K935477 — AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD (August 1, 1994)
  • K943457 — AS/3 PRESSURE TEMPERATURE MODULE, M-PT (July 27, 1994)

Other clearances for product code DRI

  • K902493 — CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR (July 6, 1990)
  • K822316 — HEART MONITOR BRACELET ALARM (September 21, 1982)
  • K802326 — PRESSURE MONITORING LINES (October 10, 1980)

FDA data resources