The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Pro 1000 Monitor, Model 1000.
| Device ID | K002248 |
| 510k Number | K002248 |
| Device Name: | DINAMAP PRO 1000 MONITOR, MODEL 1000 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CRITIKON COMPANY,LLC 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
| Contact | Thomas J English |
| Correspondent | Thomas J English CRITIKON COMPANY,LLC 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
| Product Code | DXN |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSF |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-25 |
| Decision Date | 2000-09-21 |