The following data is part of a premarket notification filed by Mir Medical Intl. Research Srl with the FDA for Minispir; Spirolab Iii.
| Device ID | K061875 |
| 510k Number | K061875 |
| Device Name: | MINISPIR; SPIROLAB III |
| 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 | 2006-07-03 |
| Decision Date | 2006-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052990321674 | K061875 | 000 |
| 08052990321667 | K061875 | 000 |
| 08052990321001 | K061875 | 000 |
| 08052990321049 | K061875 | 000 |