The following data is part of a premarket notification filed by Mir Medical Intl. Research Srl with the FDA for Mir Spirobank Spirometer.
| Device ID | K983909 |
| 510k Number | K983909 |
| Device Name: | MIR SPIROBANK SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | MIR MEDICAL INTL. RESEARCH SRL VICOLO MADDALENA 22/A Albano Laziale, Roma, IT 00041 |
| Contact | Simon Fowler |
| Correspondent | Simon Fowler MIR MEDICAL INTL. RESEARCH SRL VICOLO MADDALENA 22/A Albano Laziale, Roma, IT 00041 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-03 |
| Decision Date | 1998-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B279MIR9105101R1 | K983909 | 000 |