The following data is part of a premarket notification filed by Zan Messgerate Gmbh with the FDA for Zan Lung-function Lab.
| Device ID | K052328 |
| 510k Number | K052328 |
| Device Name: | ZAN LUNG-FUNCTION LAB |
| Classification | Calculator, Pulmonary Function Data |
| 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 | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-25 |
| Decision Date | 2005-12-22 |
| Summary: | summary |