FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOREHAB SYSTEM
K Number: K011823
·
Decision Sep 6, 2001
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
10
Review Days
87
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Basic Information
- Device Name
- BIOREHAB SYSTEM
- K Number
- K011823
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nicolet Biomedical, Inc.
- Date Received
- June 11, 2001
- Decision Date
- September 6, 2001
- Product Code
- HCC
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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Other Clearances by Nicolet Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021986 | BRAINET | Aug 23, 2002 | Substantially Equivalent |
| K021144 | SUBDURAL STRIP ELECTRODE | Jun 24, 2002 | Substantially Equivalent |
| K020218 | SNAP EEG MONITOR | Apr 22, 2002 | Substantially Equivalent |
| K020955 | NICOLET ELECTROCAUTERY DETECTOR | Apr 17, 2002 | Substantially Equivalent |
| K011818 | STERILE EMG ELECTRODES | Sep 6, 2001 | Substantially Equivalent |
| K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES | Mar 19, 2001 | Substantially Equivalent |
| K991054 | BRAVO MULTI-MODALITY SYSTEM | Nov 3, 1999 | Substantially Equivalent |
| K971331 | SATELLITE | Jun 25, 1997 | Substantially Equivalent |
| K950270 | NMI SOFTWARE | May 15, 1995 | Substantially Equivalent |