The following data is part of a premarket notification filed by Physiometrix, Inc. with the FDA for Sedline Sedation Monitor With Frontal Psi And Sedtrace Eeg Electrose Set.
Device ID | K051874 |
510k Number | K051874 |
Device Name: | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET |
Classification | Index-generating Electroencephalograph Software |
Applicant | PHYSIOMETRIX, INC. FIVE BILLERICA PARK, 101 BILLERICA AVE. North Billerica, MA 01862 |
Contact | Dawn E Frazer |
Correspondent | Dawn E Frazer PHYSIOMETRIX, INC. FIVE BILLERICA PARK, 101 BILLERICA AVE. North Billerica, MA 01862 |
Product Code | OLW |
Subsequent Product Code | GXY |
Subsequent Product Code | OLT |
Subsequent Product Code | OMC |
Subsequent Product Code | ORT |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-11 |
Decision Date | 2005-09-02 |
Summary: | summary |