Canon Surgical Auto Keratometer SK-1
FDA 510(k) K871936 · Canon USA, Inc.
510(k) numberK871936
Submission
- Device name
- Canon Surgical Auto Keratometer SK-1
- Applicant
- Canon USA, Inc.
Jericho, NY, US - Received
- May 18, 1987
- Decision date
- June 19, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HLQ – Keratoscope, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1350
- Specialty
- Ophthalmic
Other 510(k)s with product code HLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003299 | Opd-Scan, Models ARK-10000 and ARK-9000HLQ · Traditional | Nidek Co., Ltd. | 03/09/2001SESU |
| K973756 | Eye Sys VistaHLQ · Traditional | Eyesys Technologies, Inc. | 11/13/1997SE |
| K964290 | EyechekHLQ · Traditional | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 01/09/1997SE |
| K945382 | Technomed C-Scan Color Ellipsoid TopometerHLQ · Traditional | Expertech Assoc., Inc. | 01/31/1995SE |
| K944207 | Topographic Modeling System 2 TMS-2HLQ · Traditional | Computed Anatomy, Inc. | 12/07/1994SE |
| K944616 | Keratron Corneal TopographerHLQ · Traditional | Alliance Medical Marketinig | 11/22/1994SE |
| K940647 | Orbscan(Tm) KeratometerHLQ · Traditional | Orbtek, Inc. | 07/06/1994SE |
| K933556 | EH-270 Corneal TopographerHLQ · Traditional | Visioptic, Inc. | 11/02/1993SE |
| K923435 | Corneal Topography SystemHLQ · Traditional | Par Microsystems Corp. | 02/16/1993SE |
| K922253 | Keratoref L60HLQ · Traditional | Luneau Ophtalmologie SA | 06/19/1992SE |
More from Luneau Ophtalmologie SA
| 510(k) | Device | Decision |
|---|---|---|
| K090623 | Digital Radiography CXDI-40G CompactMQB · Traditional | 03/24/2009SE |
| K033624 | Pacs Software Solution 2003LLZ · Special | 12/15/2003SE |
| K031633 | Canon Inc., Digital Radiography, Model CXDI-40CMQB · Traditional | 06/11/2003SE |
| K031629 | Canon Non-Mydriatic Retinal Camera, Model Cr-DgiHKI · Traditional | 06/06/2003SE |
| K023750 | Cannon Digital Radiography Model CXDI-40GMQB · Traditional | 11/22/2002SE |
| K023586 | Dr-Er Verfsion of Canon X-Ray Digital CamerasMQB · Special | 11/05/2002SE |
| K003689 | Canon X-Ray Digital Camera, Model CXDI-31IXK · Traditional | 01/02/2002SE |
| K992606 | Canon Laser Blood Flowmeter (CLBF) Model 100HLI · Traditional | 06/21/2000SE |
| K992547 | Canon X-Ray Digital Camera, Model CXDI-22MQB · Traditional | 10/13/1999SE |
| K981556 | Canon X-Ray Digital Camera CXDI-11MQB · Traditional | 11/04/1998SE |
Questions and answers
When was Canon Surgical Auto Keratometer SK-1 cleared by the FDA?
Canon Surgical Auto Keratometer SK-1 (K871936) received a 510(k) decision of Substantially Equivalent on June 19, 1987, 32 days after the submission was received.
What is the product code of K871936?
The FDA product code is HLQ – Keratoscope, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1350.