The following data is part of a premarket notification filed by Respironics New Jersey, Inc. with the FDA for Myneb Nebulizer, Model Rdd100.
| Device ID | K053203 |
| 510k Number | K053203 |
| Device Name: | MYNEB NEBULIZER, MODEL RDD100 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRONICS NEW JERSEY, INC. 41 CANFIELD RD. Cedar Grove, NJ 07009 |
| Contact | Lauren Ziegler |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-16 |
| Decision Date | 2005-12-20 |
| Summary: | summary |