The following data is part of a premarket notification filed by Advanced Mechanical Technology, Inc. with the FDA for Biomechanics Force Platform/# Or6-5-1000 & 2000.
Device ID | K883130 |
510k Number | K883130 |
Device Name: | BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 |
Classification | Platform, Force-measuring |
Applicant | ADVANCED MECHANICAL TECHNOLOGY, INC. 151 CALIFORNIA ST. Newton, CA 02158 |
Contact | Joseph Gerstann |
Correspondent | Joseph Gerstann ADVANCED MECHANICAL TECHNOLOGY, INC. 151 CALIFORNIA ST. Newton, CA 02158 |
Product Code | KHX |
CFR Regulation Number | 890.1575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-26 |
Decision Date | 1988-10-24 |