RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR

Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

ALBION INSTRUMENTS

The following data is part of a premarket notification filed by Albion Instruments with the FDA for Rascal Ii Respiratory And Anesthetic Gas Monitor.

Pre-market Notification Details

Device IDK902021
510k NumberK902021
Device Name:RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
ClassificationAnalyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Applicant ALBION INSTRUMENTS 4745 WILEY POST WAY,650 PLAZA 6 Salt Lake City,  UT  84116
ContactHibdon, Ms
CorrespondentHibdon, Ms
ALBION INSTRUMENTS 4745 WILEY POST WAY,650 PLAZA 6 Salt Lake City,  UT  84116
Product CodeCBQ  
CFR Regulation Number868.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-03
Decision Date1990-10-09

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.