FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
STERILE DISPOSABLES FOR MER
K Number: K120098
·
Decision Jun 12, 2012
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
57
Applicant Total
8
Review Days
152
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Basic Information
- Device Name
- STERILE DISPOSABLES FOR MER
- K Number
- K120098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alpha Omega Engineering , Ltd.
- Date Received
- January 12, 2012
- Decision Date
- June 12, 2012
- Product Code
- GZL
- 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 |
|---|---|---|---|
| GZL | Electrode, Depth | FDA class 2 | Neurology |
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Other Clearances by Alpha Omega Engineering , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250601 | Neuro Omega System; NeuroSmart System | Mar 30, 2025 | Substantially Equivalent |
| K220553 | Neuro Omega System, NeuroSmart System | Sep 16, 2022 | Substantially Equivalent |
| K191739 | Sterile LeadConfirm | Jan 2, 2020 | Substantially Equivalent |
| K172042 | NeuroNav System, NeuroSmart System | Feb 27, 2018 | Substantially Equivalent |
| K171581 | Neuro Omega System | Dec 22, 2017 | Substantially Equivalent |
| K123796 | NEURO OMEGA SYSTEM | Apr 5, 2013 | Substantially Equivalent |
| K052527 | NEUROPROBES | Apr 12, 2006 | Substantially Equivalent |