The following data is part of a premarket notification filed by Avec Scientific Design Corp. with the FDA for Irrigation Pressure Monitor.
| Device ID | K872544 |
| 510k Number | K872544 |
| Device Name: | IRRIGATION PRESSURE MONITOR |
| Classification | Arthroscope |
| Applicant | AVEC SCIENTIFIC DESIGN CORP. 605 SOUTH 19TH ST. Philadelphia, PA 19146 |
| Contact | Aaron Heintz |
| Correspondent | Aaron Heintz AVEC SCIENTIFIC DESIGN CORP. 605 SOUTH 19TH ST. Philadelphia, PA 19146 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-29 |
| Decision Date | 1987-09-04 |