The following data is part of a premarket notification filed by Nutec, Inc. with the FDA for Hand-held Nebulizer.
| Device ID | K940257 |
| 510k Number | K940257 |
| Device Name: | HAND-HELD NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | NUTEC, INC. 1 S 241 NORTH FLANDERS LN. Winfield, IL 60190 |
| Contact | Charles F Cosentino |
| Correspondent | Charles F Cosentino NUTEC, INC. 1 S 241 NORTH FLANDERS LN. Winfield, IL 60190 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-19 |
| Decision Date | 1994-10-13 |