The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Poseidon Cardiac Monitoring System (pcms).
| Device ID | K964408 |
| 510k Number | K964408 |
| Device Name: | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) |
| Classification | Electrocardiograph |
| Applicant | INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Contact | Herbert J Semler, M.d. |
| Correspondent | Herbert J Semler, M.d. INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-07-23 |
| Summary: | summary |