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510(k) K954962

SPACELABS MEDICAL MULTIGAS ANALYZER by Spacelabs, Inc. — Product Code CBR

K954962 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "SPACELABS MEDICAL MULTIGAS ANALYZER". The FDA issued a decision of Substantially Equivalent on May 31, 1996. The device falls under product code CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1700. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1996
Date Received
October 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1700
Review Panel
AN
Submission Type

Other clearances by Spacelabs, Inc.

  • K951605 — SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM (July 14, 1995)
  • K950779 — HEART RATE VARIABILITY SOFTWARE OPTION (April 25, 1995)
  • K941165 — COMET CAPNOGRAPH MODULE (October 6, 1994)
  • K923788 — SPACE LABS MODEL 90560 (December 6, 1993)
  • K912742 — ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE (April 20, 1992)
  • K913038 — SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (October 4, 1991)
  • K905065 — DEFIBRILLATOR LEAD ADAPTER (April 12, 1991)
  • K910029 — PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (January 31, 1991)
  • K896903 — FIRST MEDIC MODEL 510 (December 27, 1990)
  • K904318 — LOCAL REPORT GENERATOR (December 18, 1990)

Other clearances for product code CBR

  • K112173 — SPEACELABS MULTIGAS MODULE (October 5, 2011)
  • K053599 — SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (April 19, 2006)
  • K904843 — OSCAR(TM) II CAPNOMETER & PULSE OXIMETER (April 9, 1991)
  • K853360 — N20 TEST (September 3, 1985)

FDA data resources