The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Dinamap Pro 1000 Monitor With Superstat, Model 1000.
| Device ID | K022834 |
| 510k Number | K022834 |
| Device Name: | DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORP.BLVD. Tampa, FL 33614 |
| Contact | Melissa Robinson |
| Correspondent | Melissa Robinson GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORP.BLVD. Tampa, FL 33614 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-26 |
| Decision Date | 2003-05-13 |
| Summary: | summary |