FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
MINI WRIGHT LR AFS
K Number: K952713
·
Decision Mar 29, 1996
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
10
Review Days
289
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Basic Information
- Device Name
- MINI WRIGHT LR AFS
- K Number
- K952713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clement Clarke, Inc.
- Date Received
- June 14, 1995
- Decision Date
- March 29, 1996
- Product Code
- BZH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K914896 | FRIEDMANN ANALYSER 3 | Jan 23, 1992 | Substantially Equivalent |
| K912397 | PROFESSIONAL INDIRECT OPHTHALMOSCOPE | Oct 23, 1991 | Substantially Equivalent |
| K895953 | WRIGHT VENTILOMETER VM-1 | Feb 2, 1990 | Substantially Equivalent |
| K841430 | LASERSPEC | Dec 13, 1984 | Substantially Equivalent |
| K781313 | VISION-STIMULATOR, CAM | Jan 26, 1979 | Substantially Equivalent |