The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Volumetric Controller.
Device ID | K822216 |
510k Number | K822216 |
Device Name: | VOLUMETRIC CONTROLLER |
Classification | Bag, Reservoir |
Applicant | QUEST MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTC |
CFR Regulation Number | 868.5320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-26 |
Decision Date | 1982-08-16 |