The following data is part of a premarket notification filed by Micromed S.p.a. with the FDA for Micromed Brain Spy Plus, Embia Titanium Devices.
| Device ID | K071782 |
| 510k Number | K071782 |
| Device Name: | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | MICROMED S.P.A. VIA GIOTTO 2 Mogliano Veneto (tv), IT 31021 |
| Contact | Monica Camillo |
| Correspondent | Jan Van Lochem KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2008-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850154007079 | K071782 | 000 |