The following data is part of a premarket notification filed by Blackrock Neuromed, Llc with the FDA for Cervello Bio-potential Signal Acquistion System Product Family.
| Device ID | K122196 |
| 510k Number | K122196 |
| Device Name: | CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | BLACKROCK NEUROMED, LLC 117 WEST SOUTH STREET Oconomowoc, WI 53066 |
| Contact | John Ziobro |
| Correspondent | John Ziobro BLACKROCK NEUROMED, LLC 117 WEST SOUTH STREET Oconomowoc, WI 53066 |
| Product Code | GWQ |
| Subsequent Product Code | GWK |
| Subsequent Product Code | GWL |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-24 |
| Decision Date | 2013-05-02 |
| Summary: | summary |