The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Corometrics 5566aax Noninvasive Blood Pressure Mod.
| Device ID | K911310 |
| 510k Number | K911310 |
| Device Name: | COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-18 |
| Decision Date | 1991-06-10 |