The following data is part of a premarket notification filed by Inspired Medical Products Ltd. with the FDA for Sidestream Nebulizer.
| Device ID | K991725 |
| 510k Number | K991725 |
| Device Name: | SIDESTREAM NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INSPIRED MEDICAL PRODUCTS LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden INSPIRED MEDICAL PRODUCTS LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-20 |
| Decision Date | 1999-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730001319 | K991725 | 000 |
| 00383730001067 | K991725 | 000 |
| 00383730001074 | K991725 | 000 |
| 00383730001081 | K991725 | 000 |
| 00383730001098 | K991725 | 000 |
| 00383730001104 | K991725 | 000 |
| 00383730001111 | K991725 | 000 |
| 00383730001210 | K991725 | 000 |
| 00383730001227 | K991725 | 000 |
| 00383730001234 | K991725 | 000 |
| 00383730001241 | K991725 | 000 |
| 00383730001258 | K991725 | 000 |
| 00383730001265 | K991725 | 000 |
| 00383730001272 | K991725 | 000 |
| 00383730001289 | K991725 | 000 |
| 00383730001296 | K991725 | 000 |
| 00383730001302 | K991725 | 000 |
| 00383730001050 | K991725 | 000 |