The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Medical Multigas Analyzer.
| Device ID | K954962 |
| 510k Number | K954962 |
| Device Name: | SPACELABS MEDICAL MULTIGAS ANALYZER |
| Classification | Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) |
| Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Russ Garrison |
| Correspondent | Russ Garrison SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | CBR |
| CFR Regulation Number | 868.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-30 |
| Decision Date | 1996-05-31 |