The following data is part of a premarket notification filed by Exos, Inc. with the FDA for Clincal Hand Master System Model # Exh9000-002.
Device ID | K922940 |
510k Number | K922940 |
Device Name: | CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002 |
Classification | Dynamometer, Ac-powered |
Applicant | EXOS, INC. 2A GILL ST. Woburn, MA 01801 |
Contact | Beth Marcus |
Correspondent | Beth Marcus EXOS, INC. 2A GILL ST. Woburn, MA 01801 |
Product Code | LBB |
CFR Regulation Number | 888.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-18 |
Decision Date | 1992-10-05 |