The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Explorer Software, C700 For It Patient Vicinity Workstation.
| Device ID | K141756 |
| 510k Number | K141756 |
| Device Name: | INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Contact | Karen Provencher |
| Correspondent | Karen Provencher Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-30 |
| Decision Date | 2014-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098059916 | K141756 | 000 |
| 04049098054805 | K141756 | 000 |
| 04049098047203 | K141756 | 000 |