The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Plus Physiological Monitor Model 8700.
| Device ID | K912188 |
| 510k Number | K912188 |
| Device Name: | DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Contact | Annette M Hillring |
| Correspondent | Annette M Hillring CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-17 |
| Decision Date | 1991-12-04 |