Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000
FDA 510(k) K093298 · Keeler Instruments, Inc.
510(k) numberK093298
Submission
- Device name
- Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- October 21, 2009
- Decision date
- December 10, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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More from Canon Inc. -Medical Equipment Group
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| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
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| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
| K970029 | Keeler Spectra Indirect OphthalmoscopeHLJ · Traditional | 04/02/1997SE |
Questions and answers
When was Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000 cleared by the FDA?
Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000 (K093298) received a 510(k) decision of Substantially Equivalent on December 10, 2010, 415 days after the submission was received.
What is the product code of K093298?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.