The following data is part of a premarket notification filed by Emsi with the FDA for Gs 3000.
Device ID | K102202 |
510k Number | K102202 |
Device Name: | GS 3000 |
Classification | Stimulator, Muscle, Powered |
Applicant | EMSI 901 KING STREET SUITE 200 Alexandria, VA 22314 |
Contact | Cherita James |
Correspondent | Cherita James EMSI 901 KING STREET SUITE 200 Alexandria, VA 22314 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-04 |
Decision Date | 2010-11-23 |
Summary: | summary |