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 |