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 | K060254 |
| 510k Number | K060254 |
| 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 | Karen A Iorio |
| Correspondent | Karen A Iorio 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 | 2006-02-01 |
| Decision Date | 2006-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675053682 | K060254 | 000 |