FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRAVO MULTI-MODALITY SYSTEM
K Number: K991054
·
Decision Nov 3, 1999
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
10
Review Days
218
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Basic Information
- Device Name
- BRAVO MULTI-MODALITY SYSTEM
- K Number
- K991054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nicolet Biomedical, Inc.
- Date Received
- March 30, 1999
- Decision Date
- November 3, 1999
- Product Code
- GWQ
- 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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|---|---|---|---|
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| K011818 | STERILE EMG ELECTRODES | Sep 6, 2001 | Substantially Equivalent |
| K011823 | BIOREHAB SYSTEM | Sep 6, 2001 | Substantially Equivalent |
| K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES | Mar 19, 2001 | Substantially Equivalent |
| K971331 | SATELLITE | Jun 25, 1997 | Substantially Equivalent |
| K950270 | NMI SOFTWARE | May 15, 1995 | Substantially Equivalent |