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510(k) K902021

RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR by Albion Instruments — Product Code CBQ

K902021 is an FDA 510(k) premarket notification submitted by Albion Instruments for the device "RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR". The FDA issued a decision of Substantially Equivalent on October 9, 1990. The device falls under product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)), a Class II device regulated under 21 CFR 868.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1990
Date Received
May 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class
Class II
Regulation Number
868.1500
Review Panel
AN
Submission Type

Other clearances for product code CBQ

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  • K994188 — MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (May 19, 2000)
  • K962648 — OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (January 17, 1997)
  • K931439 — OHMEDA MODEL 5330 ANESTHETIC MONITOR (October 19, 1993)
  • K926451 — DATASCOPE MULTINEX II (August 25, 1993)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)
  • K923276 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (July 21, 1993)
  • K922876 — AS/3 COP MODULE (July 21, 1993)
  • K930303 — DATASCOPE MULTINEX ID PLUS (June 16, 1993)
  • K914295 — ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (April 10, 1992)

FDA data resources