The following data is part of a premarket notification filed by Oxford Instruments Medical Ltd. with the FDA for Sonicaid One.
| Device ID | K023618 |
| 510k Number | K023618 |
| Device Name: | SONICAID ONE |
| Classification | System, Monitoring, Perinatal |
| Applicant | OXFORD INSTRUMENTS MEDICAL LTD. MANOR WAY Old Woking, Surrey, GB Gu22 9ju |
| Contact | Michael Edwards |
| Correspondent | Michael Edwards OXFORD INSTRUMENTS MEDICAL LTD. MANOR WAY Old Woking, Surrey, GB Gu22 9ju |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-29 |
| Decision Date | 2003-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968025265 | K023618 | 000 |