The following data is part of a premarket notification filed by Zan Messgerate Gmbh with the FDA for Flowhandy Zan100 Usb.
| Device ID | K052176 |
| 510k Number | K052176 |
| Device Name: | FLOWHANDY ZAN100 USB |
| Classification | Spirometer, Diagnostic |
| Applicant | ZAN MESSGERATE GMBH 908 MAIN STREET Louisville, CO 80027 |
| Contact | Jim Lewis |
| Correspondent | Jim Lewis ZAN MESSGERATE GMBH 908 MAIN STREET Louisville, CO 80027 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-10 |
| Decision Date | 2006-01-12 |
| Summary: | summary |