Panels › Physical Medicine › Product code IKN · Class 2
Electromyograph, Diagnostic
Regulation 890.1375
0510(k)s in 12 months (75 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in IKN
| Company | 510(k)s | Recalls |
|---|---|---|
| Nicolet Biomedical Instruments | 6 | 0 |
| Fasstech | 3 | 0 |
| Teca, Inc. | 3 | 0 |
| Aaron Laboratories, Inc. | 2 | 0 |
| Advantage Medical Division of Cme Telemetrix | 2 | 0 |
| Bio-Logic Systems Corp. | 2 | 0 |
| Cadwell Laboratories, Inc. | 2 | 0 |
| Dorsavi, Ltd. | 2 | 0 |
| Excel Tech. , Ltd. | 2 | 0 |
| Life-Tech Instruments, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 4, 1987 | K864660 | MODEL M402 EMG MONITOR Bio-Logic Devices | IKN |
| Jan 30, 1987 | K864408 | EMG-1, MOTOR NERVE MONITOR Algotek, Inc. | IKN |
| Jan 28, 1987 | K864641 | VENTEX-IA Ventech Corp. | IKN |
| Dec 29, 1986 | K864630 | KC/EMG DIAGNOSTIC ELECTROMYOGRAPH Chattanooga Group, Inc. | IKN |
| Aug 7, 1986 | K862236 | MYOLAB II, MODEL ML-200 Motion Control, Inc. | IKN |
| Dec 27, 1985 | K853804 | VICON (MODIFICATION) Oxford Metrics, Inc. | IKN |
| Aug 10, 1984 | K842649 | BATH TUB TRANSFER CHAIR Guardian Products Co., Inc. | IKN |
| Aug 3, 1984 | K842956 | NICOLET VIKING Nicolet Biomedical Instruments | IKN |
| Jul 20, 1984 | K842613 | COMPACT VISUAL Nicolet Biomedical Instruments | IKN |
| Jul 20, 1984 | K842612 | COMPACT AUDITORY Nicolet Biomedical Instruments | IKN |
| Jul 20, 1984 | K842611 | CA2000 Nicolet Biomedical Instruments | IKN |
| Dec 27, 1983 | K833927 | ELECTRO-MYOSCOPE 85 Biomedical Design Instruments | IKN |
| Jul 12, 1983 | K830702 | NICOLET EMG SATELLITE Nicolet Biomedical Instruments | IKN |
| Jan 14, 1983 | K823562 | EMG MODULES FOR POLYGRAPH SYSTEM Nihon Kohden America, Inc. | IKN |
| Oct 6, 1982 | K822624 | O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 Del Mar Avionics | IKN |
| Sep 7, 1982 | K821910 | ANESTHESIA & BRAIN MONITOR Datex Division Instrumentarium Corp. | IKN |
| May 21, 1982 | K821237 | NEUROMATIC 2000 Disa Electronics | IKN |
| Oct 13, 1981 | K812715 | TECA #TE 8 Teca, Inc. | IKN |
| Nov 26, 1980 | K802637 | TECA MODEL-10 ELECTROMYOGRAPH Teca, Inc. | IKN |
| Apr 21, 1980 | K800648 | CADWELL 7200 Cadwell Laboratories, Inc. | IKN |
| Aug 16, 1979 | K791235 | CADWELL 7000 ELECTROMYOGRAPH MACHINE Cadwell Laboratories, Inc. | IKN |
| Apr 23, 1979 | K790664 | MODEL 1309 AUDIO MONITOR Life-Tech Instruments, Inc. | IKN |
| Sep 20, 1978 | K781399 | TECA MODEL B9 ELECTROMYOGRAPH Teca, Inc. | IKN |
| May 19, 1978 | K780541 | PRESSURE MODULES MODELS 1855 & 1856 Life-Tech Instruments, Inc. | IKN |
| Nov 23, 1977 | K772005 | MYOTONE EMG MONITOR Micro Tronics Corp. | IKN |
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