The following data is part of a premarket notification filed by Respironics Healthscan, Inc. with the FDA for Hospital Spacer.
| Device ID | K032809 |
| 510k Number | K032809 |
| Device Name: | HOSPITAL SPACER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRONICS HEALTHSCAN, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-09 |
| Decision Date | 2003-11-13 |
| Summary: | summary |