The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider Monorail-pmc Pressure Monitoring Cath..
| Device ID | K896741 |
| 510k Number | K896741 |
| Device Name: | SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH. |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCHNEIDER INTL., LTD. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Contact | Howard B Wittels |
| Correspondent | Howard B Wittels SCHNEIDER INTL., LTD. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-30 |
| Decision Date | 1990-02-28 |