The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Vitalnet(tm) System (dinamap(tm), Model 2200).
| Device ID | K871418 |
| 510k Number | K871418 |
| Device Name: | VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) |
| 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 | 1987-04-08 |
| Decision Date | 1987-07-29 |