The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Intracranial Pressuring Monitoring Syst..
| Device ID | K802100 |
| 510k Number | K802100 |
| Device Name: | INTRACRANIAL PRESSURING MONITORING SYST. |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-03 |
| Decision Date | 1980-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000030261 | K802100 | 000 |
| 00763000030148 | K802100 | 000 |
| 00643169497078 | K802100 | 000 |
| 00643169496910 | K802100 | 000 |
| 00643169496842 | K802100 | 000 |