The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Modification To Infinity Explorer.
| Device ID | K040945 |
| 510k Number | K040945 |
| Device Name: | MODIFICATION TO INFINITY EXPLORER |
| Classification | System, Network And Communication, Physiological Monitors |
| 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 | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-12 |
| Decision Date | 2004-05-12 |
| Summary: | summary |