The following data is part of a premarket notification filed by Profile Therapeutics Plc with the FDA for I-neb Insight Aad System.
| Device ID | K052941 |
| 510k Number | K052941 |
| Device Name: | I-NEB INSIGHT 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-20 |
| Decision Date | 2005-12-09 |
| Summary: | summary |