The following data is part of a premarket notification filed by Picofemto Llc with the FDA for Cliniscansm Eeg.
| Device ID | K141883 |
| 510k Number | K141883 |
| Device Name: | CLINISCANSM EEG |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | PICOFEMTO LLC 131 W. 35TH STREET, 8TH FLOOR New York, NY 10001 |
| Contact | Srikant Krishna |
| Correspondent | Srikant Krishna PICOFEMTO LLC 228 East 45th St., 2nd Floor New York, NY 10001 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-11 |
| Decision Date | 2015-05-15 |
| Summary: | summary |