The following data is part of a premarket notification filed by Medicotest, Inc. with the FDA for Nf-50-e Disposable Ecg Electrode.
Device ID | K902407 |
510k Number | K902407 |
Device Name: | NF-50-E DISPOSABLE ECG ELECTRODE |
Classification | Electrode, Electrocardiograph |
Applicant | MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 St. Louis, MO 63102 |
Contact | John I Alber |
Correspondent | John I Alber MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 St. Louis, MO 63102 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-31 |
Decision Date | 1990-07-31 |