FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TONOSHIELD TONOMETER SHIELD
K Number: K923877
·
Decision Sep 30, 1992
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
17
Review Days
58
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Basic Information
- Device Name
- TONOSHIELD TONOMETER SHIELD
- K Number
- K923877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oasis Medical, Inc.
- Date Received
- August 3, 1992
- Decision Date
- September 30, 1992
- Product Code
- HKY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
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