The following data is part of a premarket notification filed by Respironics Ltd. with the FDA for Sidestream Plus.
| Device ID | K062689 |
| 510k Number | K062689 |
| Device Name: | SIDESTREAM PLUS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRONICS LTD. 41 CANFIELD ROAD Cedar Grove, NJ 07009 |
| Contact | Lauren Ziegler |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2007-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730004402 | K062689 | 000 |
| 00383730001333 | K062689 | 000 |
| 00383730001340 | K062689 | 000 |
| 00383730001357 | K062689 | 000 |
| 00383730001364 | K062689 | 000 |
| 00383730001371 | K062689 | 000 |
| 00383730001388 | K062689 | 000 |
| 00383730001395 | K062689 | 000 |
| 00383730001401 | K062689 | 000 |
| 00383730001418 | K062689 | 000 |
| 00383730001326 | K062689 | 000 |