The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Vital Signs Monitor 1846 Sx & 1846p Sx.
| Device ID | K844839 |
| 510k Number | K844839 |
| Device Name: | DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
| Contact | Melanie Sabo |
| Correspondent | Melanie Sabo 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 | 1984-12-12 |
| Decision Date | 1985-04-01 |