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 |