The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Disposable Icp Pressure Transducer.
| Device ID | K940648 |
| 510k Number | K940648 |
| Device Name: | CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Marvin L Sussman, Ph.d. |
| Correspondent | Marvin L Sussman, Ph.d. CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-15 |
| Decision Date | 1995-03-01 |