FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYLAB40
K Number: K070903
·
Decision Jul 2, 2007
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
7
Review Days
91
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Basic Information
- Device Name
- MYLAB40
- K Number
- K070903
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Esaote Europe B.V.
- Date Received
- April 2, 2007
- Decision Date
- July 2, 2007
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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Other Clearances by Esaote Europe B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K161168 | MyLabSix Ultrasound System | Sep 2, 2016 | Substantially Equivalent |
| K141486 | MYLABSIX ULTRASOUND SYSTEM | Jul 11, 2014 | Substantially Equivalent |
| K101605 | MYLABONE ULTRASOUND SYSTEM | Aug 31, 2010 | Substantially Equivalent |
| K083882 | MYLABFIVE | Jan 30, 2009 | Substantially Equivalent |
| K062598 | IMT.LAB SOFTWARE | Oct 31, 2006 | Substantially Equivalent |
| K061755 | MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM | Aug 7, 2006 | Substantially Equivalent |