The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Sigma Isc Echocardiograph System.
Device ID | K852543 |
510k Number | K852543 |
Device Name: | KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM |
Classification | Echocardiograph |
Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Contact | George Cho |
Correspondent | George Cho KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Product Code | DXK |
CFR Regulation Number | 870.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-14 |
Decision Date | 1985-09-20 |