SELF CHECK
Analyzer, Pacemaker Generator Function
INSTROMEDIX, INC.
The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Self Check.
Pre-market Notification Details
| Device ID | K791762 |
| 510k Number | K791762 |
| Device Name: | SELF CHECK |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | INSTROMEDIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-28 |
| Decision Date | 1979-09-21 |
Trademark Results [SELF CHECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SELF CHECK 85380815 4178157 Live/Registered |
United States Department of Homeland Security 2011-07-26 |
 SELF CHECK 74070681 1674689 Dead/Cancelled |
STARKEY LABORATORIES, INC. 1990-06-12 |
 SELF CHECK 73236021 1154745 Dead/Cancelled |
Instromedix, Inc. 1979-10-22 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.