FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMG ACCESSORY FOR POSTUROGRAPHY
K Number: K901732
·
Decision Sep 10, 1991
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
5
Review Days
511
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EMG ACCESSORY FOR POSTUROGRAPHY
- K Number
- K901732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Neurocom International, Inc.
- Date Received
- April 17, 1990
- Decision Date
- September 10, 1991
- 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