The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Medicomp Cpap Nasal Cannula.
| Device ID | K861280 |
| 510k Number | K861280 |
| Device Name: | MEDICOMP CPAP NASAL CANNULA |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | MEDICOMP, INC. 411 FREEMONT ST. Anoka, MN 55303 |
| Contact | Duncan G Johnson |
| Correspondent | Duncan G Johnson MEDICOMP, INC. 411 FREEMONT ST. Anoka, MN 55303 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-07 |
| Decision Date | 1986-05-09 |