The following data is part of a premarket notification filed by Sense Technology, Inc. with the FDA for Force Recording And Analysis System, Model 01.
Device ID | K940085 |
510k Number | K940085 |
Device Name: | FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01 |
Classification | Manipulator, Plunger-like Joint |
Applicant | SENSE TECHNOLOGY, INC. 3251 OLD FRANKSTOWN RD. Pittsburgh, PA 15239 |
Contact | Joseph M Evans |
Correspondent | Joseph M Evans SENSE TECHNOLOGY, INC. 3251 OLD FRANKSTOWN RD. Pittsburgh, PA 15239 |
Product Code | LXM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-07 |
Decision Date | 1994-12-07 |