The following data is part of a premarket notification filed by Respironics New Jersey, Inc. with the FDA for Litetouch Mask.
| Device ID | K100285 |
| 510k Number | K100285 |
| Device Name: | LITETOUCH MASK |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRONICS NEW JERSEY, INC. 5 WOOD HOLLOW ROAD Parsippany, NJ 07054 |
| Contact | Lauren Ziegler |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-01 |
| Decision Date | 2010-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730000800 | K100285 | 000 |
| 00383730000794 | K100285 | 000 |
| 00383730000787 | K100285 | 000 |
| 00383730000770 | K100285 | 000 |
| 00383730000763 | K100285 | 000 |
| 00383730000756 | K100285 | 000 |
| 00383730000749 | K100285 | 000 |
| 00383730000732 | K100285 | 000 |
| 00383730000725 | K100285 | 000 |