The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Manifold & Nebulizer, Universal.
| Device ID | K772068 |
| 510k Number | K772068 |
| Device Name: | MANIFOLD & NEBULIZER, UNIVERSAL |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INSPIRON CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-01 |
| Decision Date | 1977-11-15 |