The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Medi-comp Neonatal Oxygen Hood.
| Device ID | K851666 |
| 510k Number | K851666 |
| Device Name: | MEDI-COMP NEONATAL OXYGEN HOOD |
| Classification | Tent, Oxygen |
| Applicant | MEDICOMP, INC. 411 FREEMONT ST. Anoka, MN 55303 |
| Contact | Duncan C Johnson |
| Correspondent | Duncan C Johnson MEDICOMP, INC. 411 FREEMONT ST. Anoka, MN 55303 |
| Product Code | BYL |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-08-06 |