FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
FIAB SPA, MODELS F7244, F7233, F7234, F7277
K Number: K100333
·
Decision Jun 21, 2010
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
7
Review Days
136
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Basic Information
- Device Name
- FIAB SPA, MODELS F7244, F7233, F7234, F7277
- K Number
- K100333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fiab Spa
- Date Received
- February 5, 2010
- Decision Date
- June 21, 2010
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
| K192210 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Oct 10, 2019 | Substantially Equivalent |
| K180047 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Nov 8, 2018 | Substantially Equivalent |
| K123361 | ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM | Feb 27, 2013 | Substantially Equivalent |
| K103783 | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC | Jun 16, 2011 | Substantially Equivalent |
| K083428 | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY | Sep 1, 2009 | Substantially Equivalent |
| K091163 | PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST | Jul 22, 2009 | Substantially Equivalent |