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510(k) K942737

POET IQ WITH FIVE AGENT CAPABILITY by Criticare Systems, Inc. — Product Code CBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1995
Date Received
June 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1620
Review Panel
AN
Submission Type

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Other clearances for product code CBS

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  • K951366 — RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (August 2, 1995)
  • K950101 — RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR (March 21, 1995)
  • K943458 — AS/3 AIRWAY MODULE (February 14, 1995)
  • K932389 — 8100 ANESTHETIC AGENT MONITOR (December 3, 1993)
  • K905754 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (June 17, 1991)
  • K896629 — NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR (February 12, 1990)
  • K896216 — HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A (January 16, 1990)