The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Sensa-cuff, Models Infant, Child, Adult.
| Device ID | K022482 |
| 510k Number | K022482 |
| Device Name: | SENSA-CUFF, MODELS INFANT, CHILD, ADULT |
| Classification | Blood Pressure Cuff |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORPORATE BLVD. Tampa, FL 33614 |
| Contact | Melissa Robinson |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-07-29 |
| Decision Date | 2002-08-13 |
| Summary: | summary |