The following data is part of a premarket notification filed by Eko Scann Ab with the FDA for Devetherm.
Device ID | K822873 |
510k Number | K822873 |
Device Name: | DEVETHERM |
Classification | Phlebograph, Impedance |
Applicant | EKO SCANN AB 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | DQB |
CFR Regulation Number | 870.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-27 |
Decision Date | 1983-03-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DEVETHERM 73343083 1229509 Dead/Cancelled |
Nilsson; Erling 1981-12-23 |