The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Masimo Set Sp02 Pod.
| Device ID | K061329 |
| 510k Number | K061329 |
| Device Name: | INFINITY MASIMO SET SP02 POD |
| Classification | Oximeter |
| Applicant | Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Thomas Mcintosh |
| Correspondent | Thomas Mcintosh Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-12 |
| Decision Date | 2006-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098050746 | K061329 | 000 |
| 04049098050739 | K061329 | 000 |
| 04049098004985 | K061329 | 000 |
| 04049098004978 | K061329 | 000 |
| 04049098004961 | K061329 | 000 |
| 04049098004954 | K061329 | 000 |
| 04049098004909 | K061329 | 000 |
| 04049098004084 | K061329 | 000 |
| 04049098003032 | K061329 | 000 |