The following data is part of a premarket notification filed by Sensortek, Inc. with the FDA for Vibratron Ii, Vibration Sensitivity Tester.
Device ID | K863607 |
510k Number | K863607 |
Device Name: | VIBRATRON II, VIBRATION SENSITIVITY TESTER |
Classification | Device, Vibration Threshold Measurement |
Applicant | SENSORTEK, INC. 154 HURON AVE. Clifton, NJ 07013 |
Contact | Ronald R Feller |
Correspondent | Ronald R Feller SENSORTEK, INC. 154 HURON AVE. Clifton, NJ 07013 |
Product Code | LLN |
CFR Regulation Number | 882.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-16 |
Decision Date | 1986-12-03 |