The following data is part of a premarket notification filed by R. Scott Bell with the FDA for Bel Blood Level Detector.
Device ID | K823712 |
510k Number | K823712 |
Device Name: | BEL BLOOD LEVEL DETECTOR |
Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
Applicant | R. SCOTT BELL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTW |
CFR Regulation Number | 870.4340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-10 |
Decision Date | 1983-02-07 |