The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Stimuplex Onvision System.
| Device ID | K192914 |
| 510k Number | K192914 |
| Device Name: | Stimuplex Onvision System |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Contact | Gert De Vries |
| Correspondent | Gert De Vries Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2020-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838090668 | K192914 | 000 |