The following data is part of a premarket notification filed by Medic-aid Ltd. with the FDA for Ventstream Drug Nebulizer.
| Device ID | K933535 |
| 510k Number | K933535 |
| Device Name: | VENTSTREAM DRUG NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDIC-AID LTD. HOOK LANE, PAGHAM, Sussex, U.k. Po21 3pp, GB |
| Contact | Howard Burnett |
| Correspondent | Howard Burnett MEDIC-AID LTD. HOOK LANE, PAGHAM, Sussex, U.k. Po21 3pp, GB |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-21 |
| Decision Date | 1994-01-24 |