The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Pressure Monitor Manometric Sys..
| Device ID | K771265 |
| 510k Number | K771265 |
| Device Name: | PRESSURE MONITOR MANOMETRIC SYS. |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-13 |
| Decision Date | 1977-11-22 |