The following data is part of a premarket notification filed by Viratek, Inc. with the FDA for Aerosol Delivery Hood.
| Device ID | K882396 |
| 510k Number | K882396 |
| Device Name: | AEROSOL DELIVERY HOOD |
| Classification | Tent, Oxygen |
| Applicant | VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Contact | Joseph Creighton |
| Correspondent | Joseph Creighton VIRATEK, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Product Code | BYL |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-10 |
| Decision Date | 1988-08-01 |