The following data is part of a premarket notification filed by Clinical Neuro Systems Llc. with the FDA for Clinical Neuro Syst Monitorr Ext Csf Drain/moni Sy.
| Device ID | K920156 |
| 510k Number | K920156 |
| Device Name: | CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | CLINICAL NEURO SYSTEMS LLC. 870 SERENIDAD PLACE Goleta, CA 93117 |
| Contact | Stephen W Laguette |
| Correspondent | Stephen W Laguette CLINICAL NEURO SYSTEMS LLC. 870 SERENIDAD PLACE Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-14 |
| Decision Date | 1992-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780112136 | K920156 | 000 |