The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Trident Nmt Pod.
| Device ID | K042003 |
| 510k Number | K042003 |
| Device Name: | INFINITY TRIDENT NMT POD |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Penelope H Greco |
| Correspondent | Penelope H Greco Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-26 |
| Decision Date | 2004-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098051149 | K042003 | 000 |
| 04049098007177 | K042003 | 000 |
| 04049098007139 | K042003 | 000 |
| 04049098007023 | K042003 | 000 |
| 04049098006026 | K042003 | 000 |