The following data is part of a premarket notification filed by Cardinal Health with the FDA for Airlife Nebulizer Cap.
| Device ID | K072119 |
| 510k Number | K072119 |
| Device Name: | AIRLIFE NEBULIZER CAP |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Cardinal Health 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Ned Levine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-01 |
| Decision Date | 2007-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30889483598508 | K072119 | 000 |