The following data is part of a premarket notification filed by Profile Therapeutics Plc with the FDA for I-neb Aad System.
| Device ID | K042991 |
| 510k Number | K042991 |
| Device Name: | I-NEB AAD SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PROFILE THERAPEUTICS PLC CORPORATE SERVICES 1010 MURRY RIDGE LANE Murrysville, PA 15668 -8525 |
| Contact | Barbara Campbell |
| Correspondent | Barbara Campbell PROFILE THERAPEUTICS PLC CORPORATE SERVICES 1010 MURRY RIDGE LANE Murrysville, PA 15668 -8525 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-09-23 |
| Summary: | summary |