The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Am-pak.
| Device ID | K912436 |
| 510k Number | K912436 |
| Device Name: | AM-PAK |
| Classification | Amplifier, Physiological Signal |
| Applicant | CNS, INC. 1250 PARK RD. Chanhassen, MN 55317 |
| Contact | John F Stolte |
| Correspondent | John F Stolte CNS, INC. 1250 PARK RD. Chanhassen, MN 55317 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-03 |
| Decision Date | 1991-10-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AM-PAK 73588605 not registered Dead/Abandoned |
NATURE'S WAY PRODUCTS, INC. 1986-03-17 |
![]() AM-PAK 73295774 not registered Dead/Abandoned |
BEECHAM INC. 1981-02-05 |
![]() AM-PAK 73143927 1090263 Dead/Expired |
AMERICAN AIR FILTER COMPANY, INC. 1977-10-06 |