The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Dinamap Pro Series Monitor, Models 110n,210n,310n,410n.
| Device ID | K021435 |
| 510k Number | K021435 |
| Device Name: | DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N |
| Classification | Monitor, Physiological, Patient (without 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 | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-05-22 |
| Summary: | summary |