The following data is part of a premarket notification filed by Microvaper Devices with the FDA for Pocket Neb.
| Device ID | K142541 |
| 510k Number | K142541 |
| Device Name: | POCKET NEB |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MicroVaper Devices 2682 West Fairbanks Ave. Winter Park, FL 32789 |
| Contact | Scott Faris |
| Correspondent | Terrence O'brien MicroVapor Devices 2682 West Fairbanks Ave. Winter Park, FL 32789 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-10 |
| Decision Date | 2016-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856702006051 | K142541 | 000 |
| 00856702006037 | K142541 | 000 |
| 10856702006010 | K142541 | 000 |
| 00860002180601 | K142541 | 000 |