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.
Device ID | K053599 |
510k Number | K053599 |
Device Name: | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES |
Classification | Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) |
Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
Contact | Al Van Houdt |
Correspondent | Al Van Houdt SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
Product Code | CBR |
CFR Regulation Number | 868.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-23 |
Decision Date | 2006-04-19 |
Summary: | summary |