The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Ferris Ecg Electrode W/hydrogel.
Device ID | K873682 |
510k Number | K873682 |
Device Name: | FERRIS ECG ELECTRODE W/HYDROGEL |
Classification | Electrode, Electrocardiograph |
Applicant | FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Contact | Demetra Lalagos |
Correspondent | Demetra Lalagos FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-14 |
Decision Date | 1987-12-29 |