FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER
K Number: K855247
·
Decision Feb 19, 1987
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
152
Review Days
423
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Basic Information
- Device Name
- INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER
- K Number
- K855247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- December 23, 1985
- Decision Date
- February 19, 1987
- 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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