FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
EvaQMax Smoke Evacuation System
K Number: K192035
·
Decision Aug 29, 2019
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
17
Review Days
30
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Basic Information
- Device Name
- EvaQMax Smoke Evacuation System
- K Number
- K192035
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio Protech, Inc.
- Date Received
- July 30, 2019
- Decision Date
- August 29, 2019
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Bio Protech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes | Jun 3, 2016 | Substantially Equivalent |
| K153019 | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes | Mar 21, 2016 | Substantially Equivalent |
| K143103 | PROPENCIL Smoke Pencil | Jul 16, 2015 | Substantially Equivalent |
| K142099 | CUTANEOUS ELECTRODES | Nov 17, 2014 | Substantially Equivalent |
| K111270 | REUSABLE STIMULATING ELECTRODES | Sep 13, 2011 | Substantially Equivalent |
| K100246 | MAX-IF1000 | Nov 24, 2010 | Substantially Equivalent |
| K091248 | MAXEMS, MODELS 1000 AND 2000 | Nov 30, 2009 | Substantially Equivalent |
| K092732 | PROPENCIL ESU PENCIL | Nov 25, 2009 | Substantially Equivalent |
| K092761 | PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C | Nov 24, 2009 | Substantially Equivalent |
| K083148 | TELECTRODE WET GEL ECG ELECTRODE | Nov 7, 2008 | Substantially Equivalent |