FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KRYSTAL-X WIFI
K Number: K070505
·
Decision Apr 5, 2007
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
6
Review Days
43
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Basic Information
- Device Name
- KRYSTAL-X WIFI
- K Number
- K070505
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Owandy
- Date Received
- February 21, 2007
- Decision Date
- April 5, 2007
- Product Code
- MUH
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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|---|---|---|---|
| K133271 | OPTEO, VIDEOGRAPH HD | Apr 28, 2014 | Substantially Equivalent |
| K130443 | I-MAX TOUCH 3D | Jun 14, 2013 | Substantially Equivalent |
| K093105 | VISTEO | Oct 18, 2010 | Substantially Equivalent |
| K083057 | I-MAX TOUCH | Jun 2, 2009 | Substantially Equivalent |
| K062403 | IMAX CEPH DIGITAL X-RAY SENSOR | Nov 14, 2006 | Substantially Equivalent |