FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: OCU-FILM TIP COVER
K Number: K070534
·
Decision Mar 27, 2007
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
9
Review Days
29
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Basic Information
- Device Name
- MODIFICATION TO: OCU-FILM TIP COVER
- K Number
- K070534
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Reichert, Inc.
- Date Received
- February 26, 2007
- Decision Date
- March 27, 2007
- 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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Other Clearances by Reichert, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | May 1, 2024 | Substantially Equivalent |
| K141954 | XCEL 455 SLIT LAMP | Oct 15, 2014 | Substantially Equivalent |
| K081756 | OCULAR RESPONSE ANALYZER | Aug 7, 2008 | Substantially Equivalent |
| K071839 | SOCT COPERNICUS, MODEL 15205 | Feb 27, 2008 | Substantially Equivalent |
| K063750 | XCEL 255 SLIT LAMP | Dec 20, 2006 | Substantially Equivalent |
| K061330 | PSL PORTABLE SLIT LAMP | May 25, 2006 | Substantially Equivalent |
| K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) | Oct 28, 2004 | Substantially Equivalent |
| K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | Jan 20, 2004 | Substantially Equivalent |