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 |