FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARVISION
K Number: K112380
·
Decision Nov 22, 2011
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
31
Review Days
97
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Basic Information
- Device Name
- CLEARVISION
- K Number
- K112380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Midmark Corp.
- Date Received
- August 17, 2011
- Decision Date
- November 22, 2011
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C | Jan 7, 2013 | Substantially Equivalent |
| K090670 | MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER | Jul 7, 2009 | Substantially Equivalent |
| K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER | Mar 3, 2003 | Substantially Equivalent |
| K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM | Oct 18, 2000 | Substantially Equivalent |
| K992744 | MIDMARK M4*9 EASYCLAVE STEAM STERILIZER | Jan 10, 2000 | Substantially Equivalent |
| K990189 | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Apr 19, 1999 | Substantially Equivalent |
| K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Nov 30, 1994 | Substantially Equivalent |
| K926463 | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES | Oct 21, 1994 | Substantially Equivalent |
| K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE | Mar 28, 1994 | Substantially Equivalent |
| K923730 | MODEL 561 C-ARM PROCEDURES STRETCHER | Feb 9, 1994 | Substantially Equivalent |