The following data is part of a premarket notification filed by Conmed Integrated Systems (cmis) with the FDA for Conmed Integrated Systems Nurses Assistant.
| Device ID | K031979 |
| 510k Number | K031979 |
| Device Name: | CONMED INTEGRATED SYSTEMS NURSES ASSISTANT |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | CONMED INTEGRATED SYSTEMS (CMIS) 1815 NW 169TH PLACE SUITE 4020 Beaverton, OR 97006 |
| Contact | C. Jeff Lipps |
| Correspondent | C. Jeff Lipps CONMED INTEGRATED SYSTEMS (CMIS) 1815 NW 169TH PLACE SUITE 4020 Beaverton, OR 97006 |
| Product Code | FSY |
| Subsequent Product Code | FET |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GEI |
| Subsequent Product Code | HET |
| Subsequent Product Code | HIF |
| Subsequent Product Code | LMC |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-26 |
| Decision Date | 2003-07-25 |
| Summary: | summary |