Medical Device Manufacturer · US , Gilroy , CA

Chalgren Enterprises, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1989
21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Chalgren Enterprises, Inc. Neurology

20 devices
1-20 of 20
Cleared Jun 22, 1999
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550,...
K982950 · IKT
Neurology · 305d
Cleared Jun 13, 1996
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP,...
K960591 · IKT
Neurology · 122d
Cleared Jan 29, 1996
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
K955335 · IKT
Neurology · 70d
Cleared Jan 22, 1996
EMG DISC RECORDING ELECTRODE
K953354 · GXY
Neurology · 189d
Cleared Jan 22, 1996
EMG RECORDING RING ELECTRODE
K953356 · GXY
Neurology · 189d
Cleared Jan 22, 1996
EMG DISC RECORDING ELECTRODE
K953361 · GXY
Neurology · 189d
Cleared Dec 06, 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952690 · GXY
Neurology · 177d
Cleared Dec 06, 1995
EMG DISC RECORDING ELECTRODE WITH PIN
K952908 · GXY
Neurology · 166d
Cleared Oct 31, 1995
RE-USABLE MONOPOLAR NEEDLE
K953886 · IKT
Neurology · 75d
Cleared Oct 31, 1995
RE-USABLE CONCENTRIC NEEDLE
K953887 · IKT
Neurology · 75d
Cleared Oct 06, 1995
22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN
K953219 · GXY
Neurology · 88d
Cleared Oct 06, 1995
32MM NICKEL PLATED DISC ELECTRODE
K953220 · GXY
Neurology · 88d
Cleared Aug 25, 1994
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
K931029 · IKT
Neurology · 542d
Cleared Feb 12, 1993
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
K924521 · IKT
Neurology · 157d
Cleared Feb 10, 1993
REUSABLE FINGER CLIP RECORDING ELECTRODE
K925706 · GXY
Neurology · 90d
Cleared Oct 05, 1992
REUSABLE DUAL DISC BAR RECORDING ELECTRODES
K923665 · JXE
Neurology · 75d
Cleared Sep 11, 1992
REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
K921504 · JXE
Neurology · 164d
Cleared Mar 16, 1992
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
K912282 · IKT
Neurology · 293d
Cleared Mar 16, 1992
DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K912283 · IKT
Neurology · 298d
Cleared Dec 22, 1989
DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)
K896370 · GXZ
Neurology · 46d
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