SPIROTEL
Spirometer, Diagnostic
MIR MEDICAL INTL. RESEARCH SRL
The following data is part of a premarket notification filed by Mir Medical Intl. Research Srl with the FDA for Spirotel.
Pre-market Notification Details
| Device ID | K130784 |
| 510k Number | K130784 |
| Device Name: | SPIROTEL |
| Classification | Spirometer, Diagnostic |
| Applicant | MIR MEDICAL INTL. RESEARCH SRL VIA DEL MAGGIOLINO 125 Roma, IT 00155 |
| Contact | Gerda Van Houts |
| Correspondent | Gerda Van Houts 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-21 |
| Decision Date | 2013-10-30 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052990320493 | K130784 | 000 |
| 08052990320578 | K130784 | 000 |
| 08052990320523 | K130784 | 000 |
| 08052990320486 | K130784 | 000 |
Trademark Results [SPIROTEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIROTEL 79039481 3462550 Live/Registered |
MIR S.r.l.; MEDICAL INTERNATIONAL RESEARCH 2007-03-20 |
 SPIROTEL 78716270 3138802 Live/Registered |
MIR S.R.L. MEDICAL INTERNATIONAL RESEARCH 2005-09-20 |
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