The following data is part of a premarket notification filed by Mir Medical Intl. Research Srl with the FDA for Spirolab, Spirolab Ii.
| Device ID | K052140 |
| 510k Number | K052140 |
| Device Name: | SPIROLAB, SPIROLAB II |
| Classification | Spirometer, Diagnostic |
| Applicant | MIR MEDICAL INTL. RESEARCH SRL VIA DEL MAGGIOLINO 125 Roma, IT 00155 |
| Contact | Simon Fowler |
| Correspondent | Simon Fowler MIR MEDICAL INTL. RESEARCH SRL VIA DEL MAGGIOLINO 125 Roma, IT 00155 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-08 |
| Decision Date | 2006-03-16 |
| Summary: | summary |