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 |