The following data is part of a premarket notification filed by Respironics New Jersey, Inc. with the FDA for Optichamber Advantage Anti-static Valved Holding Chamber.
| Device ID | K072418 |
| 510k Number | K072418 |
| Device Name: | OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRONICS NEW JERSEY, INC. 41 CANFIELD RD. Cedar Grove, NJ 07009 |
| 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 | Yes |
| Date Received | 2007-08-28 |
| Decision Date | 2007-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730003894 | K072418 | 000 |
| 00383730000633 | K072418 | 000 |
| 00383730000626 | K072418 | 000 |
| 00383730000497 | K072418 | 000 |
| 00383730000329 | K072418 | 000 |
| 00383730000268 | K072418 | 000 |
| 00383730000183 | K072418 | 000 |
| 00383730000176 | K072418 | 000 |
| 00383730000145 | K072418 | 000 |