The following data is part of a premarket notification filed by Central Media with the FDA for Ecg Based Media.
Device ID | K873267 |
510k Number | K873267 |
Device Name: | ECG BASED MEDIA |
Classification | Culture Media, Enriched |
Applicant | CENTRAL MEDIA 10386 ROCKINGHAM DR. Sacramento, CA 95827 |
Contact | Rebecca Clark |
Correspondent | Rebecca Clark CENTRAL MEDIA 10386 ROCKINGHAM DR. Sacramento, CA 95827 |
Product Code | KZI |
CFR Regulation Number | 866.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-11 |
Decision Date | 1987-11-04 |