The following data is part of a premarket notification filed by Y with the FDA for Ivac(r) Volumetric Controller - Model 262+.
Device ID | K894487 |
510k Number | K894487 |
Device Name: | IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+ |
Classification | Controller, Infusion, Intravascular, Electronic |
Applicant | Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
Contact | G Christian |
Correspondent | G Christian Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
Product Code | LDR |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-18 |
Decision Date | 1989-09-27 |