The following data is part of a premarket notification filed by Critikon Company, L.l.c. with the FDA for Dinamap Advanced Nibp Module.
Device ID | K000500 |
510k Number | K000500 |
Device Name: | DINAMAP ADVANCED NIBP MODULE |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | CRITIKON COMPANY, L.L.C. 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
Contact | Thomas J English |
Correspondent | Thomas J English CRITIKON COMPANY, L.L.C. 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-14 |
Decision Date | 2000-05-26 |