The following data is part of a premarket notification filed by Y with the FDA for Model Ez-1 Sing Chan/ez-2 Dual Channel Infus Pump.
Device ID | K931549 |
510k Number | K931549 |
Device Name: | MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP |
Classification | Pump, Infusion |
Applicant | Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
Contact | Jennifer S Hankard |
Correspondent | Jennifer S Hankard Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-29 |
Decision Date | 1993-10-12 |