FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED
K Number: K905522
·
Decision Jun 11, 1991
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
2
Review Days
183
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Basic Information
- Device Name
- LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED
- K Number
- K905522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Laboratory Equipment Corp.
- Date Received
- December 10, 1990
- Decision Date
- June 11, 1991
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Laboratory Equipment Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K890519 | LABSONICS MAMM-O-MATE MODEL NO. 918084-1 | May 3, 1989 | Substantially Equivalent |