The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Intra Compartmental Pressure Monitor.
| Device ID | K873684 |
| 510k Number | K873684 |
| Device Name: | ACE INTRA COMPARTMENTAL PRESSURE MONITOR |
| Classification | Monitor, Pressure, Intracompartmental |
| Applicant | ACE MEDICAL CO. DAVID W. SCHLERF 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David Schlerf |
| Correspondent | David Schlerf ACE MEDICAL CO. DAVID W. SCHLERF 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | LXC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-14 |
| Decision Date | 1988-01-20 |