The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Patient Monitor, Models Dash 3000, 4000 And 5000.
| Device ID | K051367 |
| 510k Number | K051367 |
| Device Name: | PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
| Contact | Tyler Sedone |
| Correspondent | Tyler Sedone GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-25 |
| Decision Date | 2005-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103084 | K051367 | 000 |
| 00840682103060 | K051367 | 000 |