The following data is part of a premarket notification filed by Suntech Medical Instruments, Inc. with the FDA for Accutracker Dx.
| Device ID | K913844 |
| 510k Number | K913844 |
| Device Name: | ACCUTRACKER DX |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SUNTECH MEDICAL INSTRUMENTS, INC. 8608 JERSEY COURT Raleigh, NC 27613 |
| Contact | Chris Mcneely |
| Correspondent | Chris Mcneely SUNTECH MEDICAL INSTRUMENTS, INC. 8608 JERSEY COURT Raleigh, NC 27613 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-28 |
| Decision Date | 1992-07-14 |