The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Dinamap Procare Series Monitor, Models 100n, 200n, 300n, 400n.
| Device ID | K022193 |
| 510k Number | K022193 |
| Device Name: | DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2002-08-01 |
| Summary: | summary |