The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Model 556 Monitor W/24-hr. Trend Recall/modified.
| Device ID | K910665 |
| 510k Number | K910665 |
| Device Name: | MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Brian R Barry |
| Correspondent | Brian R Barry GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-11 |
| Decision Date | 1991-12-31 |