The following data is part of a premarket notification filed by Healthware Corp. with the FDA for Diacare Monitoring System.
| Device ID | K882001 |
| 510k Number | K882001 |
| Device Name: | DIACARE MONITORING SYSTEM |
| Classification | Medical Computers And Software |
| Applicant | HEALTHWARE CORP. 1713 COLE MILL RD. Durham, NC 27712 |
| Contact | S Surwit,phd |
| Correspondent | S Surwit,phd HEALTHWARE CORP. 1713 COLE MILL RD. Durham, NC 27712 |
| Product Code | LNX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-12 |
| Decision Date | 1988-10-18 |