The following data is part of a premarket notification filed by Ferraris Medical, Inc. with the FDA for Pocketspacer.
| Device ID | K992038 |
| 510k Number | K992038 |
| Device Name: | POCKETSPACER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | FERRARIS MEDICAL, INC. 555 THIRTEENTH STREET, N.W. Washington, DC |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan FERRARIS MEDICAL, INC. 555 THIRTEENTH STREET, N.W. Washington, DC |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-16 |
| Decision Date | 1999-09-09 |
| Summary: | summary |