Henson - Hamblin CFS 2000 Central Field Screen
FDA 510(k) K864467 · Keeler Instruments, Inc.
510(k) numberK864467
Submission
- Device name
- Henson - Hamblin CFS 2000 Central Field Screen
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- November 12, 1986
- Decision date
- December 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOO – Perimeter, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1605
- Specialty
- Ophthalmic
Other 510(k)s with product code HOO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941723 | Welch Allyn Glaucoma DetectorHOO · Traditional | Welch Allyn, Inc. | 06/06/1994SE |
| K930448 | Marco Projection PerimeterHOO · Traditional | Marco Ophthalmic, Inc. | 06/21/1993SE |
| K873912 | Richmond Visual Field ScreenerHOO · Traditional | Richmond Products, Inc. | 11/02/1987SE |
| K860115 | Digilab Cambridge PerimeterHOO · Traditional | Bio-Rad | 02/27/1986SE |
| K832800 | Automatic Tangent Screen 50HOO · Traditional | CooperVision, Inc. | 09/29/1983SE |
More from CooperVision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | 12/08/2011SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| 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 |
Questions and answers
When was Henson - Hamblin CFS 2000 Central Field Screen cleared by the FDA?
Henson - Hamblin CFS 2000 Central Field Screen (K864467) received a 510(k) decision of Substantially Equivalent on December 15, 1986, 33 days after the submission was received.
What is the product code of K864467?
The FDA product code is HOO – Perimeter, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.