The following data is part of a premarket notification filed by Magnetic Moments, Llc. with the FDA for Stepping Kinematic Imaging Platform (skip).
Device ID | K992892 |
510k Number | K992892 |
Device Name: | STEPPING KINEMATIC IMAGING PLATFORM (SKIP) |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MAGNETIC MOMENTS, LLC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk MAGNETIC MOMENTS, LLC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-27 |
Decision Date | 1999-09-16 |
Summary: | summary |