DRR · Class II · 21 CFR 870.2050

FDA Product Code DRR: Amplifier And Signal Conditioner, Biopotential

Leading manufacturers include Hewlett-Packard Co., C.R. Bard, Inc. and Gould, Inc..

24
Total
24
Cleared
60d
Avg days
1976
Since

FDA 510(k) Cleared Amplifier And Signal Conditioner, Biopotential Devices (Product Code DRR)

24 devices
1–24 of 24
Cleared Jan 28, 1992
HORIZON 9000/HIS OPTION AMPLIFIER
K914381
Mennen Medical, Inc.
Cardiovascular · 117d
Cleared Jul 22, 1991
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
K911935
Gould, Inc.
Cardiovascular · 82d
Cleared Jan 19, 1988
BARD BIOPOTENTIAL AMPLIFIER
K874441
C.R. Bard, Inc.
Cardiovascular · 83d
Cleared Nov 27, 1981
EPC FILTER
K813123
Codman & Shurtleff, Inc.
Cardiovascular · 23d
Cleared Nov 26, 1980
HP MODEL 8880A FILTER
K802686
Hewlett-Packard Co.
Cardiovascular · 29d
Cleared Oct 11, 1979
MODEL 15055A MAINFRAME
K791964
Hewlett-Packard Co.
Cardiovascular · 10d
Cleared Feb 13, 1978
ESIS MODULE
K780043
Datascope Corp.
Cardiovascular · 35d
Cleared Nov 22, 1977
AMPLIFIER MODULE, 78211A ECG
K772132
Hewlett-Packard Co.
Cardiovascular · 8d
Cleared Nov 09, 1977
ECG AMPLIFIER/R WAVE TRIGGER
K771976
G.D. Searle and Co.
Radiology · 23d
Cleared Aug 30, 1977
PATIENT MONITORS MODELS 78701A/78702A
K771572
Hewlett-Packard Co.
Cardiovascular · 15d
Cleared Feb 14, 1977
ELGILOY STYLET
K770243
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Dec 09, 1976
DISPLAY MONITOR (MODEL 78301A)
K761056
Hewlett-Packard Co.
Cardiovascular · 24d

About Product Code DRR - Regulatory Context