The following data is part of a premarket notification filed by Respironics Respiratory Drug Delivery (uk) Ltd. with the FDA for I-neb Aad System With Tim; I-neb Insight Aad System.
| Device ID | K102454 |
| 510k Number | K102454 |
| Device Name: | I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2011-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730003627 | K102454 | 000 |