FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K Number: K093298
·
Decision Dec 10, 2010
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
60
Review Days
415
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Basic Information
- Device Name
- PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
- K Number
- K093298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Keeler Instruments, Inc.
- Date Received
- October 21, 2009
- Decision Date
- December 10, 2010
- 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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|---|---|---|---|
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| K062412 | CRYOMATIC | Nov 6, 2006 | Substantially Equivalent |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | May 23, 2006 | Substantially Equivalent |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Nov 26, 2003 | Substantially Equivalent |
| K992954 | KEELER CRYO MASTER & PROBES | Dec 21, 1999 | Substantially Equivalent |
| K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | Mar 25, 1999 | Substantially Equivalent |
| K973064 | KEELER TEARSCOPE-PLUS | Apr 7, 1998 | Substantially Equivalent |
| K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Apr 2, 1997 | Substantially Equivalent |