The following data is part of a premarket notification filed by Medcraft Corp. with the FDA for Comp-act Iv.
| Device ID | K791795 |
| 510k Number | K791795 |
| Device Name: | COMP-ACT IV |
| Classification | Electrocardiograph |
| Applicant | MEDCRAFT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-14 |
| Decision Date | 1979-09-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COMP-ACT IV 73268734 1164519 Dead/Cancelled |
Hittman Corporation 1980-07-02 |