The following data is part of a premarket notification filed by Erie Medical with the FDA for Erie-neb.
| Device ID | K861865 |
| 510k Number | K861865 |
| Device Name: | ERIE-NEB |
| Classification | Compressor, Air, Portable |
| Applicant | ERIE MEDICAL 4000 SOUTH 13TH ST. Milwaukee, WI 53221 |
| Contact | Steven A Case |
| Correspondent | Steven A Case ERIE MEDICAL 4000 SOUTH 13TH ST. Milwaukee, WI 53221 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-15 |
| Decision Date | 1986-07-01 |