510(k) K000812
- Device
- NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
- Applicant
- NEUROSOFT, INC.
- 510(k) number
- K000812
- Product code
- IKN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-05-17
- Date received
- 2000-03-13
- Regulation
- 890.1375
- Classification name
- Electromyograph, Diagnostic
- Medical specialty
- Physical Medicine
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID B JONES
- Address
- 5700 Cromo Dr. Suite 100 El Paso TX US 79912 79912
FDA Registration Numbers#
- 9612330
- 1930027
- 3003935342
- 3005706667
- 8043933
- 9612389
- 8030229
- 3017636737
- 1047843
- 3010872373
- 3013501110
- 9611252
- 3014251656
- 1526711
- 1221763
- 1045254
- 3006128100
- 2031093
- 3010123206
- 3004413879
- 3016438694
- 2183946
- 3004753785
- 3030412764
- 1048735
- 2183164
- 3007014520
- 3003851073
- 3006639944
- 3007147067
- 9615126
- 1223851
- 9615102
- 3008881376
- 3023852420
- 3001687738
- 3010611950
- 3008361680
- 9612501
- 3012263546
- 3018094310
- 3007962724
- 3043543260
- 2133772
- 2183613
- 3009959868
- 2027467
- 2023374
- 2032098
- 3009973505
- 3008483389
- 3019878714
- 3020018
- 3005581270
- 3009503584
- 2184161
- 3006418479
- 3009973336
- 3006783837
- 3016852448
- 3010209365
- 3010047454
- 3008773490
- 2080783
- 3009050824
- 3013246402
- 2031966
- 3009144915
- 1056553
Source Documents#
Other 510(k) Records For Product Code IKN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172743 | Natus VikingQuest | Natus Neurology Incorporated | 2017-12-19 |
| K163150 | ViMove2 | Dorsavi, Ltd. | 2017-07-14 |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017-03-01 |
| K142494 | ViMove | Dorsavi, Ltd. | 2015-05-28 |
| K131094 | VIMOVE | Dorsa VI Pty., Ltd. | 2014-07-11 |
| K123902 | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) | Oktx, LLC | 2013-09-13 |
| K123399 | MYOVISION 3.0 WIREFREE SYSTEM | Precision Biometrics, Inc. | 2013-08-01 |
| K113074 | CMAP PRO | Medical Technologies, Inc. | 2012-02-02 |
| K102610 | FOCUS EMG DEVICE | Teleemg, LLC USA | 2011-03-04 |
| K110048 | CERSR ELECTROMYOGRAPHY SYSTEM | Spinematrix, Inc. | 2011-01-26 |
| K083679 | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | Uroval | 2009-09-11 |
| K073415 | NEMUS SYSTEM; NEMUS PC PERIPHERAL | Eb Neuro S.P.A. | 2008-05-23 |
| K063447 | INSIGHT DISCOVERY | Fasstech | 2007-08-16 |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Excel Tech. , Ltd. | 2005-10-28 |
| K031995 | COMPREHENSIVE NEUROMUSCULAR PROFILER | Medical Technologies Unlimited, Inc. | 2004-01-07 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases