FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SINUSON 810 ULTRASOUND SCANNER
K Number: K827663
·
Decision Aug 16, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
2
Review Days
47
Basic Information
- Device Name
- SINUSON 810 ULTRASOUND SCANNER
- K Number
- K827663
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- AM LABS, INC.
- Date Received
- June 30, 1982
- Decision Date
- August 16, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by AM LABS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K803264 | SUNLAMP | Jun 2, 1981 | Substantially Equivalent |