The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Electrophysiological System To Monitor Skin Temp..
| Device ID | K860458 |
| 510k Number | K860458 |
| Device Name: | ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP. |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-05 |
| Decision Date | 1986-08-12 |