SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES

Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)

SPACELABS MEDICAL INC.

The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Spacelabs Medical Multigas Analyzer Module 91518 And Accessories.

Pre-market Notification Details

Device IDK053599
510k NumberK053599
Device Name:SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
ClassificationAnalyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
Applicant SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah,  WA  98029
ContactAl Van Houdt
CorrespondentAl Van Houdt
SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah,  WA  98029
Product CodeCBR  
CFR Regulation Number868.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-23
Decision Date2006-04-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.