FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROPACK MICRO, MODEL MED-9100A SERIES
K Number: K010590
·
Decision Jun 28, 2001
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
74
Applicant Total
166
Review Days
121
Basic Information
- Device Name
- NEUROPACK MICRO, MODEL MED-9100A SERIES
- K Number
- K010590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NIHON KOHDEN AMERICA, INC.
- Date Received
- February 27, 2001
- Decision Date
- June 28, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKN), ordered by most recent decision date.
Natus VikingQuest
FDA 510(k)
FDA Class 2
·Physical Medicine
ViMove2
FDA 510(k)
FDA Class 2
·Physical Medicine
Cadwell Sierra Summit, Cadwell Sierra Ascent
FDA 510(k)
FDA Class 2
·Physical Medicine
ViMove
FDA 510(k)
FDA Class 2
·Physical Medicine
VIMOVE
FDA 510(k)
FDA Class 2
·Physical Medicine
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by NIHON KOHDEN AMERICA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX | Mar 22, 2012 | Substantially Equivalent |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | Mar 16, 2012 | Substantially Equivalent |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | Jul 9, 2010 | Substantially Equivalent |
| K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | Mar 2, 2009 | Substantially Equivalent |
| K083271 | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY | Dec 24, 2008 | Substantially Equivalent |
| K082785 | NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES | Nov 26, 2008 | Substantially Equivalent |
| K071969 | SEN-4100 ELECTRIC STIMULATOR | Oct 6, 2008 | Substantially Equivalent |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | Aug 29, 2008 | Substantially Equivalent |
| K073550 | PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION | Mar 28, 2008 | Substantially Equivalent |
| K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES | Feb 26, 2008 | Substantially Equivalent |