FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 30 CLASSIC PNEUMATONOMETER
K Number: K002395
·
Decision Dec 11, 2000
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
56
Applicant Total
82
Review Days
126
Basic Information
- Device Name
- MODEL 30 CLASSIC PNEUMATONOMETER
- K Number
- K002395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- XOMED, INC.
- Date Received
- August 7, 2000
- Decision Date
- December 11, 2000
- Product Code
- HKX
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
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| K993582 | MODIFICATION TO LASER-SHIELD II | Jan 20, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |
| K993112 | XOMED ENT RF SYSTEM | Dec 9, 1999 | Substantially Equivalent |