The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Radial-cuf Non-invasive Blood Pressure Cuff.
| Device ID | K123996 |
| 510k Number | K123996 |
| Device Name: | RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Mary Carter |
| Correspondent | Mary Carter GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682106108 | K123996 | 000 |
| 00840682105811 | K123996 | 000 |
| 00840682105781 | K123996 | 000 |
| 00840682105750 | K123996 | 000 |