The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aerochamber Z-stat Plus Valved Holding Chamber.
| Device ID | K052332 |
| 510k Number | K052332 |
| Device Name: | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER |
| Classification | Holding Chambers, 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 | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-26 |
| Decision Date | 2005-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50604351887157 | K052332 | 000 |
| 50604351787150 | K052332 | 000 |
| 50604351797104 | K052332 | 000 |
| 50604351797159 | K052332 | 000 |
| 50604351797500 | K052332 | 000 |
| 50604351797555 | K052332 | 000 |
| 50604351807100 | K052332 | 000 |
| 50604351807155 | K052332 | 000 |
| 50604351887102 | K052332 | 000 |
| 50604351787105 | K052332 | 000 |