The following data is part of a premarket notification filed by Alerkan Ltd with the FDA for Alerkan Spirometry Filter.
| Device ID | K111587 |
| 510k Number | K111587 |
| Device Name: | ALERKAN SPIROMETRY FILTER |
| Classification | Spirometer, Diagnostic |
| Applicant | ALERKAN LTD 1340 WEST PENNSYLVANIA AVE. San Diego, CA 92013 |
| Contact | Glen Feye |
| Correspondent | Glen Feye ALERKAN LTD 1340 WEST PENNSYLVANIA AVE. San Diego, CA 92013 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-07 |
| Decision Date | 2011-10-20 |