The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Vital Signs Monitor, Model 8100t.
| Device ID | K874378 |
| 510k Number | K874378 |
| Device Name: | DINAMAP VITAL SIGNS MONITOR, MODEL 8100T |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
| Contact | Annette M Hillring |
| Correspondent | Annette M Hillring CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-26 |
| Decision Date | 1987-12-30 |