The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Healthline Redi-neb Medication Nebulizer, Model Rn-510.
| Device ID | K080969 |
| 510k Number | K080969 |
| Device Name: | HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDI NUCLEAR CORP., INC. 4610 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Jerry Schoen |
| Correspondent | Jerry Schoen MEDI NUCLEAR CORP., INC. 4610 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-04 |
| Decision Date | 2008-07-25 |
| Summary: | summary |