The following data is part of a premarket notification filed by Inspirx, Inc. with the FDA for Inspirachamber Anti-static Valved Holding Chamber.
| Device ID | K130598 |
| 510k Number | K130598 |
| Device Name: | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | INSPIRX, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden INSPIRX, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-07 |
| Decision Date | 2013-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852367007065 | K130598 | 000 |
| 10852367007058 | K130598 | 000 |
| 00327437024011 | K130598 | 000 |