The following data is part of a premarket notification filed by Oxford Instruments Medical Systems with the FDA for Medilog Mpa-s.
| Device ID | K961638 |
| 510k Number | K961638 |
| Device Name: | MEDILOG MPA-S |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | OXFORD INSTRUMENTS MEDICAL SYSTEMS 11526 53ND ST. N Clearwater, FL 34620 |
| Contact | Charles Holz |
| Correspondent | Charles Holz OXFORD INSTRUMENTS MEDICAL SYSTEMS 11526 53ND ST. N Clearwater, FL 34620 |
| Product Code | OLV |
| 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 |