The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Nellcor Oximax Smartpod, Model Ms23997.
| Device ID | K082888 |
| 510k Number | K082888 |
| Device Name: | INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 |
| Classification | Oximeter |
| Applicant | Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Contact | Pradeep Gupta |
| Correspondent | Pradeep Gupta Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2008-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098049306 | K082888 | 000 |
| 04049098009522 | K082888 | 000 |
| 04049098009508 | K082888 | 000 |
| 04049098004657 | K082888 | 000 |
| 04049098004077 | K082888 | 000 |
| 04049098002769 | K082888 | 000 |
| 04049098002752 | K082888 | 000 |