The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Sonicaid Team.
| Device ID | K912639 |
| 510k Number | K912639 |
| Device Name: | SONICAID TEAM |
| Classification | System, Monitoring, Perinatal |
| Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Contact | Charles Holz |
| Correspondent | Charles Holz OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-14 |
| Decision Date | 1991-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968032713 | K912639 | 000 |
| 05051968032140 | K912639 | 000 |
| 05051968008237 | K912639 | 000 |