The following data is part of a premarket notification filed by Imed Corp. with the FDA for Imed(r) 980c Volumetric Infusion Pump.
Device ID | K870656 |
510k Number | K870656 |
Device Name: | IMED(R) 980C VOLUMETRIC INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
Contact | Jarboe, Ph.d. |
Correspondent | Jarboe, Ph.d. 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 | 1987-02-18 |
Decision Date | 1987-10-20 |