The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Model 556 Monitor.
Device ID | K905856 |
510k Number | K905856 |
Device Name: | MODEL 556 MONITOR |
Classification | Recorder, Paper Chart |
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 | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-15 |
Decision Date | 1991-01-11 |