The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aeroeclipse Ii Breath Actuated Nebulizer.
| Device ID | K053605 |
| 510k Number | K053605 |
| Device Name: | AEROECLIPSE II BREATH ACTUATED NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Contact | John Straatman |
| Correspondent | John Straatman TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-27 |
| Decision Date | 2006-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 62860105542023 | K053605 | 000 |
| 00762860055018 | K053605 | 000 |
| 10762860055053 | K053605 | 000 |
| 10762860055060 | K053605 | 000 |
| 10762860055428 | K053605 | 000 |
| 62860105501020 | K053605 | 000 |
| 62860105505028 | K053605 | 000 |
| 62860105506025 | K053605 | 000 |
| 62860105541026 | K053605 | 000 |
| 10762860055411 | K053605 | 000 |