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510(k) K896629

NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR by Nellcor, Inc. — Product Code CBS

K896629 is an FDA 510(k) premarket notification submitted by Nellcor, Inc. for the device "NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR". The FDA issued a decision of Substantially Equivalent on February 12, 1990. The device falls under product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1620. Nellcor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1990
Date Received
November 22, 1989
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

Other clearances by Nellcor, Inc.

  • K953472 — NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR (October 20, 1995)
  • K952316 — NELLCOR SYMPHONY N-3000 PULSE OXIMETER (August 17, 1995)
  • K952222 — NELLCOR N-20PA PORTABLE PULSE OXIMETER (August 15, 1995)
  • K942347 — NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 (May 12, 1995)
  • K945947 — NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR (March 8, 1995)
  • K944760 — DURA-Y OXYGEN TRANSDUCER, EAR CLIP (October 17, 1994)
  • K944400 — PEDI-CAP (September 27, 1994)
  • K915494 — NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 (August 6, 1993)
  • K915699 — NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 (May 27, 1993)
  • K913695 — NELLCOR(R) N-180 PULSE OXIMETER (November 13, 1991)

Other clearances for product code CBS

  • K974903 — GAS MODULE II, MODEL 0998-00-0143 (March 13, 1998)
  • K953795 — VITALMAX 4100 (July 1, 1996)
  • K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV (May 3, 1996)
  • 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)
  • K942737 — POET IQ WITH FIVE AGENT CAPABILITY (February 9, 1995)
  • K932389 — 8100 ANESTHETIC AGENT MONITOR (December 3, 1993)
  • K905754 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (June 17, 1991)
  • K896216 — HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A (January 16, 1990)

FDA data resources