The following data is part of a premarket notification filed by Micromed S.p.a with the FDA for Micromed Brain Quick System.
| Device ID | K171384 |
| 510k Number | K171384 |
| Device Name: | Micromed BRAIN QUICK System |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Micromed S.P.A Via Giotto 2 Mogliano Veneto, IT 31021 |
| Contact | Monica Camillo |
| Correspondent | J. P. Ouellette EAS Consulting Group 1700 Diagonal Road Suite 750 Alexandria, VA 22314 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-11 |
| Decision Date | 2018-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033928120910 | K171384 | 000 |