The following data is part of a premarket notification filed by Fortec Electronic Corp./nam Tai with the FDA for Fortec Mi-100, Blood Pressure Meter.
| Device ID | K862200 |
| 510k Number | K862200 |
| Device Name: | FORTEC MI-100, BLOOD PRESSURE METER |
| Classification | Computer, Blood-pressure |
| Applicant | FORTEC ELECTRONIC CORP./NAM TAI 855 MATHESON BLVD. E. UNIT 4 L4W 4L6 Mississauga, Ont., CA |
| Contact | Frank Kastenmacher |
| Correspondent | Frank Kastenmacher FORTEC ELECTRONIC CORP./NAM TAI 855 MATHESON BLVD. E. UNIT 4 L4W 4L6 Mississauga, Ont., CA |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-10 |
| Decision Date | 1986-11-18 |