The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Dinamap Procare Series Monitor; Model 100, 200, 300, 400.
| Device ID | K014255 |
| 510k Number | K014255 |
| Device Name: | DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORP.BLVD. Tampa, FL 33614 |
| Contact | Thomas English |
| Correspondent | Thomas English GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORP.BLVD. Tampa, FL 33614 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-26 |
| Decision Date | 2002-07-02 |
| Summary: | summary |