The following data is part of a premarket notification filed by Pari Innovative Manufacturers, Inc. with the FDA for Eflow Electronic Inhaler/nebulizer.
| Device ID | K033833 |
| 510k Number | K033833 |
| Device Name: | EFLOW ELECTRONIC INHALER/NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI INNOVATIVE MANUFACTURERS, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Contact | Lawrence Weinstein |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-12-10 |
| Decision Date | 2004-05-05 |
| Summary: | summary |