The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Respirgard Ii Nebulizer System.
| Device ID | K874395 |
| 510k Number | K874395 |
| Device Name: | RESPIRGARD II NEBULIZER SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | John Adams |
| Correspondent | John Adams MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1987-12-21 |