The following data is part of a premarket notification filed by Respironics New Jersey, Inc. with the FDA for Optichamber Diamond Valved Holding Chamber.
| Device ID | K110293 |
| 510k Number | K110293 |
| Device Name: | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | RESPIRONICS NEW JERSEY, INC. 5 WOOD HOLLOW ROAD Parsippany, NJ 07054 |
| Contact | Lauren Ziegler |
| Correspondent | Lauren Ziegler RESPIRONICS NEW JERSEY, INC. 5 WOOD HOLLOW ROAD Parsippany, NJ 07054 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-01 |
| Decision Date | 2011-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730003924 | K110293 | 000 |
| 00383730000206 | K110293 | 000 |
| 00383730000213 | K110293 | 000 |
| 00383730000220 | K110293 | 000 |
| 00383730000244 | K110293 | 000 |
| 00383730000251 | K110293 | 000 |
| 00383730000336 | K110293 | 000 |
| 00383730000343 | K110293 | 000 |
| 00383730000350 | K110293 | 000 |
| 00383730000374 | K110293 | 000 |
| 00383730000381 | K110293 | 000 |
| 00383730000503 | K110293 | 000 |
| 00383730000510 | K110293 | 000 |
| 00383730000527 | K110293 | 000 |
| 00383730003900 | K110293 | 000 |
| 00383730003917 | K110293 | 000 |
| 00383730000190 | K110293 | 000 |