FLS · Class II · 21 CFR 868.2377

FDA Product Code FLS: Monitor, Apnea, Facility Use

Leading manufacturers include Air-Shields, Inc., National Patent Development Corp. and Clinical Data, Inc..

16
Total
16
Cleared
112d
Avg days
1976
Since

FDA 510(k) Cleared Monitor, Apnea, Facility Use Devices (Product Code FLS)

16 devices
1–16 of 16
Cleared Feb 13, 1984
RESPIRATION MONITOR
K832999
Litton Medical Electronics
Anesthesiology · 179d
Cleared Jul 13, 1982
CLINICAL DATA APNEA DETECTOR
K821721
Clinical Data, Inc.
Anesthesiology · 33d
Cleared Aug 10, 1978
INFUSION CONTROLLER, PARENTERAL
K781216
National Patent Development Corp.
Anesthesiology · 24d
Cleared Sep 21, 1976
RESPIRATION MONITOR
K760104
Air-Shields, Inc.
Anesthesiology · 90d

About Product Code FLS - Regulatory Context