JAF · Class II · 21 CFR 892.1540

FDA Product Code JAF: Monitor, Ultrasonic, Nonfetal

Leading manufacturers include Thd Spa, Imex Medical Systems, Inc. and Summit Doppler Systems, Inc..

38
Total
38
Cleared
140d
Avg days
1978
Since
38 devices
25–38 of 38
Cleared Sep 21, 1988
MEDACORD PVL, PERSONAL VASCULAR LABORATORY
K882018
Medasonics, Inc.
Radiology · 131d
Cleared Apr 23, 1986
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
K854590
Philips Medical Systems, Inc.
Radiology · 156d
Cleared Apr 23, 1986
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
K854591
Philips Medical Systems, Inc.
Radiology · 156d
Cleared Nov 26, 1985
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
K851149
Keymed, Inc.
Radiology · 250d
Cleared Sep 19, 1985
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802
K852572
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Feb 25, 1985
EUB-40
K844128
Hitachi Medical Corp. of America
Radiology · 125d
Cleared Feb 13, 1985
VINGMED DS100 DOPPLER FLOWMETER
K843933
Vingmed, Inc.
Radiology · 131d
Cleared Nov 29, 1984
IREX 730 MECHANICAL SECTOR SCANNER
K842408
Irex Corp.
Radiology · 163d
Cleared Sep 17, 1982
HEMACOUNT WRIGHT GIEMSA STAIN PACK
K822602
Accra Laboratories, Inc.
Pathology · 21d
Cleared Jul 08, 1980
VASCULAB BI-DIRECTIONAL DOPPLER, #D10
K800768
Medasonics, Inc.
Radiology · 92d
Cleared Feb 11, 1980
AMBIVASON DR-200
K800096
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
MINIVASON 9
K800097
Kt Medical, Inc.
Radiology · 28d
Cleared Mar 02, 1978
ULTRASCOPE
K780200
L&M Ultrascope Life Monitoring Sys.
Radiology · 22d
Cleared Mar 02, 1978
SPEAKER-AMPLIFIER & RECORDER INTERFACE
K780201
L&M Ultrascope Life Monitoring Sys.
Radiology · 22d