FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Ultrasound Transducer Cover
K Number: K241662
·
Decision Aug 30, 2024
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
38
Review Days
81
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Basic Information
- Device Name
- Ultrasound Transducer Cover
- K Number
- K241662
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitrolife Sweden AB
- Date Received
- June 10, 2024
- Decision Date
- August 30, 2024
- 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
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