The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Gammaxl And Sc 6802xl With The Scio Gas Module.
| Device ID | K040188 |
| 510k Number | K040188 |
| Device Name: | INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE |
| Classification | Analyzer, Gas, Sevoflurane, Gaseous-phase (anesthetic Concentration) |
| Applicant | Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Penelope H Greco |
| Correspondent | Penelope H Greco Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | NHP |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-28 |
| Decision Date | 2004-04-14 |
| Summary: | summary |