The following data is part of a premarket notification filed by Biotrine Corp. with the FDA for Multiichallenge Nebulizer System.
| Device ID | K883704 |
| 510k Number | K883704 |
| Device Name: | MULTIICHALLENGE NEBULIZER SYSTEM |
| Classification | Compressor, Air, Portable |
| Applicant | BIOTRINE CORP. 52 DRAGON CT Woburn, MA 01801 |
| Contact | Burke, Jr. |
| Correspondent | Burke, Jr. BIOTRINE CORP. 52 DRAGON CT Woburn, MA 01801 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-30 |
| Decision Date | 1988-11-28 |