The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Pressure Monitoring Extension Line.
| Device ID | K910378 |
| 510k Number | K910378 |
| Device Name: | PRESSURE MONITORING EXTENSION LINE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
| Contact | James E Williams |
| Correspondent | James E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-04-22 |