The following data is part of a premarket notification filed by Respironics Respiratory Drug Delivery (uk) Ltd. with the FDA for Innospire Go.
| Device ID | K170853 |
| 510k Number | K170853 |
| Device Name: | InnoSpire Go |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Respironics Respiratory Drug Delivery (UK) Ltd. Chichester Business Park, City Fields Way, Tangmere Chichester, GB Po20 2ft |
| Contact | Filippo Quadrelli |
| Correspondent | Paul Dryden Respironics Respiratory Drug Delivery (UK) Ltd. C/o ProMedic 24301 Woodsage Dr. Bonita Springs, FL 36134 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-22 |
| Decision Date | 2017-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730004204 | K170853 | 000 |
| 00383730002415 | K170853 | 000 |
| 00383730000640 | K170853 | 000 |
| 00383730000565 | K170853 | 000 |
| 00383730000558 | K170853 | 000 |
| 00383730000541 | K170853 | 000 |
| 00383730000534 | K170853 | 000 |
| 00383730000169 | K170853 | 000 |
| 00383730004389 | K170853 | 000 |
| 00383730004372 | K170853 | 000 |
| 00383730002446 | K170853 | 000 |
| 00383730003849 | K170853 | 000 |
| 00383730004174 | K170853 | 000 |
| 00383730004167 | K170853 | 000 |
| 00383730004143 | K170853 | 000 |
| 00383730004051 | K170853 | 000 |
| 00383730003962 | K170853 | 000 |
| 00383730003887 | K170853 | 000 |
| 00383730003870 | K170853 | 000 |
| 00383730003863 | K170853 | 000 |
| 00383730003856 | K170853 | 000 |
| 00383730004181 | K170853 | 000 |