The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Aero-vent Aerosol Unit.
| Device ID | K865107 |
| 510k Number | K865107 |
| Device Name: | AERO-VENT AEROSOL UNIT |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | MEDI NUCLEAR CORP., INC. 4501 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Russell W King |
| Correspondent | Russell W King MEDI NUCLEAR CORP., INC. 4501 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-31 |
| Decision Date | 1987-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857863007918 | K865107 | 000 |
| 00857863007185 | K865107 | 000 |
| 00857863007208 | K865107 | 000 |
| 00857863007192 | K865107 | 000 |
| 00857863007215 | K865107 | 000 |
| 00857863007222 | K865107 | 000 |
| 00857863007246 | K865107 | 000 |
| 00857863007239 | K865107 | 000 |
| 00857863007253 | K865107 | 000 |
| 00857863007260 | K865107 | 000 |
| 00857863007338 | K865107 | 000 |
| 00857863007345 | K865107 | 000 |
| 00857863007369 | K865107 | 000 |
| 00857863007376 | K865107 | 000 |
| 00857863007178 | K865107 | 000 |