The following data is part of a premarket notification filed by Oxford Instruments, Plc. with the FDA for Medilog Vision.
Device ID | K961636 |
510k Number | K961636 |
Device Name: | MEDILOG VISION |
Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
Applicant | OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater, FL 34620 |
Contact | Charles Holz |
Correspondent | Charles Holz OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater, FL 34620 |
Product Code | OLZ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-29 |
Decision Date | 1997-01-17 |