The following data is part of a premarket notification filed by Medic-aid Ltd. with the FDA for Halolite Aad System.
| Device ID | K981772 |
| 510k Number | K981772 |
| Device Name: | HALOLITE AAD SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDIC-AID LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden MEDIC-AID LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-19 |
| Decision Date | 1998-11-03 |
| Summary: | summary |