The following data is part of a premarket notification filed by National Medical Technology with the FDA for S&w Type 888 Electrode.
Device ID | K861158 |
510k Number | K861158 |
Device Name: | S&W TYPE 888 ELECTRODE |
Classification | Electrode, Electrocardiograph |
Applicant | NATIONAL MEDICAL TECHNOLOGY ATLANTIC BANK BUILDING 20 NORTH ORANGE AVE.SUITE 1400 Orlando, FL 32801 |
Contact | Geoffrey R Eisele |
Correspondent | Geoffrey R Eisele NATIONAL MEDICAL TECHNOLOGY ATLANTIC BANK BUILDING 20 NORTH ORANGE AVE.SUITE 1400 Orlando, FL 32801 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-28 |
Decision Date | 1986-07-01 |