The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Heat And Moisture Exchanger Filter (hme).
| Device ID | K943915 |
| 510k Number | K943915 |
| Device Name: | HEAT AND MOISTURE EXCHANGER FILTER (HME) |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | MEDICOMP, INC. 11873 FLINTWOOD STREET, N.E. Coon Rapids, MN 55448 |
| Contact | Duncan G Johnson |
| Correspondent | Duncan G Johnson MEDICOMP, INC. 11873 FLINTWOOD STREET, N.E. Coon Rapids, MN 55448 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-11 |
| Decision Date | 1994-10-14 |