The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Baro-graf 24.
| Device ID | K881297 |
| 510k Number | K881297 |
| Device Name: | BARO-GRAF 24 |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Contact | Semler, M.d. |
| Correspondent | Semler, M.d. INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1988-09-16 |