The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Neb-90 Large Volume Medication Nebulizer.
| Device ID | K080657 |
| 510k Number | K080657 |
| Device Name: | NEB-90 LARGE VOLUME MEDICATION NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDI NUCLEAR CORP., INC. 4610 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Michael Mcpeck |
| Correspondent | Michael Mcpeck 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 | 2008-03-07 |
| Decision Date | 2008-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857863007840 | K080657 | 000 |
| 00857863007833 | K080657 | 000 |
| 00857863007819 | K080657 | 000 |