FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINUSVU 2500
K Number: K833222
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
5
Review Days
101
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Basic Information
- Device Name
- SINUSVU 2500
- K Number
- K833222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radionics Medical, Inc.
- Date Received
- August 19, 1983
- Decision Date
- November 28, 1983
- 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 Radionics Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844299 | CORNEOMAP 4500 | Apr 18, 1985 | Substantially Equivalent |
| K837331 | CORNEOMAP 4500 ULTRASOUND MEASUREMENT | May 9, 1983 | Substantially Equivalent |
| K827035 | OCULAR BIOMETER 4000 | Jul 22, 1982 | Substantially Equivalent |
| K810851 | SPECTRUM ANALYZER 8000 | Apr 23, 1981 | Substantially Equivalent |