FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICOLET EMG SATELLITE
K Number: K830702
·
Decision Jul 12, 1983
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
26
Review Days
127
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Basic Information
- Device Name
- NICOLET EMG SATELLITE
- K Number
- K830702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Nicolet Biomedical Instruments
- Date Received
- March 7, 1983
- Decision Date
- July 12, 1983
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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Other Clearances by Nicolet Biomedical Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K880573 | MODIFIED NICOLET VIKING SYSTEM | Mar 22, 1988 | Substantially Equivalent |
| K873736 | NICOLET DIGITAL TWO PIECE HEARING AID | Dec 8, 1987 | Substantially Equivalent |
| K873964 | NICOLET DISPOSABLE PRASS PROBE | Nov 20, 1987 | Substantially Equivalent |
| K873535 | NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM | Oct 26, 1987 | Substantially Equivalent |
| K871678 | NICOLET AMP 6R11 SYSTEM | Jul 16, 1987 | Substantially Equivalent |
| K862592 | PHOENIX SYSTEM SEVEN. | Sep 16, 1986 | Substantially Equivalent |
| K851190 | NYSTAGMOGRAPH EOG/ENG ANALYSES | Nov 27, 1985 | Substantially Equivalent |
| K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | Apr 11, 1985 | Substantially Equivalent |
| K850107 | CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE | Apr 11, 1985 | Substantially Equivalent |
| K850259 | ELECTROENCEPHALOGRAPH EEG | Apr 11, 1985 | Substantially Equivalent |