The following data is part of a premarket notification filed by Pin Dot Products, Inc. with the FDA for Mechanical Shape Sensor.
Device ID | K913510 |
510k Number | K913510 |
Device Name: | MECHANICAL SHAPE SENSOR |
Classification | System, Pressure Measurement, Intermittent |
Applicant | PIN DOT PRODUCTS, INC. 6001 GROSS POINT RD. Niles, IL 60648 -4027 |
Product Code | JFC |
CFR Regulation Number | 890.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-07 |
Decision Date | 1991-09-23 |