IYY · Class I · 21 CFR 892.1410

FDA Product Code IYY: Synchronizer, Electrocardiograph, Nuclear

Leading manufacturers include Bios, Inc., Amr Co. and Capintec, Inc..

3
Total
3
Cleared
77d
Avg days
1978
Since

FDA 510(k) Cleared Synchronizer, Electrocardiograph, Nuclear Devices (Product Code IYY)

3 devices
1–3 of 3
Cleared Feb 13, 1986
VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
K853737
Capintec, Inc.
Radiology · 160d
Cleared Mar 22, 1979
GENERATOR, R-WAVE
K790213
Amr Co.
Radiology · 51d
Cleared Apr 18, 1978
NUCLEAR STETHOSCOPE
K780510
Bios, Inc.
Radiology · 19d

About Product Code IYY - Regulatory Context