The following data is part of a premarket notification filed by Imed Corp. with the FDA for Gemini Pc-itx.
Device ID | K960512 |
510k Number | K960512 |
Device Name: | GEMINI PC-ITX |
Classification | Pump, Infusion |
Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
Contact | Dale Coleman |
Correspondent | Dale Coleman IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-05 |
Decision Date | 1996-11-21 |
Summary: | summary |