FJF — Detector, Air Bubble Class II

FDA Device Classification

FDA product code FJF covers "Detector, Air Bubble", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FJF
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K904992minntechMINNILERT AIR DETECTORFebruary 5, 1991
K891327american orthodonticsNICKLE-TITANIUM ORTHODONTIC WIREMay 10, 1989
K781330bd becton dickinson vacutainer systems preanalyticBLOOD LEVEL DETECTOR-MODEL 7601August 31, 1978
K780582hospal medicalDETECTOR, BUBBLE & FOAMJune 22, 1978
K770857cobe laboratoriesDIALYSIS MACHINE, CENTRY IIOctober 4, 1977