The following data is part of a premarket notification filed by Inhalation Plastics with the FDA for Aeromist Ii Nebulizer.
| Device ID | K901315 |
| 510k Number | K901315 |
| Device Name: | AEROMIST II NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INHALATION PLASTICS 7790 N. MERRIMAC Chicago, IL 60648 |
| Contact | James Lekkas |
| Correspondent | James Lekkas INHALATION PLASTICS 7790 N. MERRIMAC Chicago, IL 60648 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-21 |
| Decision Date | 1990-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688517319 | K901315 | 000 |
| 50351688517263 | K901315 | 000 |
| 50351688517195 | K901315 | 000 |
| 30351688410249 | K901315 | 000 |