The following data is part of a premarket notification filed by Neomedix Corp. with the FDA for Nmx-1000.
Device ID | K040584 |
510k Number | K040584 |
Device Name: | NMX-1000 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | NEOMEDIX CORP. 27452 CALLE ARROYO San Juan Capistrano, CA 92675 -2748 |
Contact | Soheila Mirhashemi |
Correspondent | Marc Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-03-05 |
Decision Date | 2004-04-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00854028002092 | K040584 | 000 |