Canon Autorefractometer R-22
FDA 510(k) K883200 · Canon USA, Inc.
510(k) numberK883200
Submission
- Device name
- Canon Autorefractometer R-22
- Applicant
- Canon USA, Inc.
Jericho, NY, US - Received
- July 28, 1988
- Decision date
- August 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKO – Refractometer, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1760
- Specialty
- Ophthalmic
Other 510(k)s with product code HKO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031831 | Topcon Model BV-1000 Automated Subjective Refraction SystemHKO · Traditional | Topcon Medical Systems, Inc. | 12/19/2003SE |
| K000327 | Wavescan Wavefront System Model HS 1HKO · Traditional | Visx, Incorporated | 05/02/2000SESU |
| K951179 | Digital Retinoscopic PhotometerHKO · Traditional | Kudi Kalu, Inc. | 05/30/1995SE |
| K945959 | Video Vision Analyzer (Viva), VRB 100HKO · Traditional | Tomey Corporation USA | 03/01/1995SE |
| K942242 | Auto Ref-Keratometer, RK-3HKO · Traditional | Cannon U.S.A., Inc. | 09/02/1994SE |
| K940516 | Auto REFF-30HKO · Traditional | Canon, Inc. | 07/12/1994SE |
| K925304 | Autoref Lensmeter RL-10HKO · Traditional | Canon USA, Inc. | 02/17/1994SE |
| K924741 | Optec 3000HKO · Traditional | Stereo Optical Co., Inc. | 04/06/1993SE |
| K924790 | Burton Auto Refractor - Model BAR-7HKO · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K924778 | Burton Auto Refractor/Keratometer - Model BARK-8HKO · Traditional | R.H. Burton Co. | 04/05/1993SE |
More from R.H. Burton Co.
| 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 Autorefractometer R-22 cleared by the FDA?
Canon Autorefractometer R-22 (K883200) received a 510(k) decision of Substantially Equivalent on August 18, 1988, 21 days after the submission was received.
What is the product code of K883200?
The FDA product code is HKO – Refractometer, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1760.