The following data is part of a premarket notification filed by Oxford Instruments Medical Systems with the FDA for Sonicaid System 8002.
| Device ID | K992607 |
| 510k Number | K992607 |
| Device Name: | SONICAID SYSTEM 8002 |
| Classification | System, Monitoring, Perinatal |
| Applicant | OXFORD INSTRUMENTS MEDICAL SYSTEMS P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith OXFORD INSTRUMENTS MEDICAL SYSTEMS P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-03 |
| Decision Date | 2001-04-27 |
| Summary: | summary |