The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Picco Pod, Model Ms16734.
| Device ID | K073113 |
| 510k Number | K073113 |
| Device Name: | INFINITY PICCO POD, MODEL MS16734 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Contact | Genci Omari |
| Correspondent | Genci Omari Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-05 |
| Decision Date | 2008-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098009485 | K073113 | 000 |
| 04049098005074 | K073113 | 000 |
| 04049098004619 | K073113 | 000 |