Canon Auto Ref Keratometer RK-1

FDA 510(k) K861415 · Canon USA, Inc.

Substantially Equivalent

510(k) numberK861415

Submission

Device name
Canon Auto Ref Keratometer RK-1
Applicant
Canon USA, Inc.
Jericho, NY, US
Received
April 15, 1986
Decision date
May 14, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

More from Canon USA, Inc.

510(k)DeviceDecision
K090623Digital Radiography CXDI-40G CompactMQB · Traditional 03/24/2009SE
K033624Pacs Software Solution 2003LLZ · Special 12/15/2003SE
K031633Canon Inc., Digital Radiography, Model CXDI-40CMQB · Traditional 06/11/2003SE
K031629Canon Non-Mydriatic Retinal Camera, Model Cr-DgiHKI · Traditional 06/06/2003SE
K023750Cannon Digital Radiography Model CXDI-40GMQB · Traditional 11/22/2002SE
K023586Dr-Er Verfsion of Canon X-Ray Digital CamerasMQB · Special 11/05/2002SE
K003689Canon X-Ray Digital Camera, Model CXDI-31IXK · Traditional 01/02/2002SE
K992606Canon Laser Blood Flowmeter (CLBF) Model 100HLI · Traditional 06/21/2000SE
K992547Canon X-Ray Digital Camera, Model CXDI-22MQB · Traditional 10/13/1999SE
K981556Canon X-Ray Digital Camera CXDI-11MQB · Traditional 11/04/1998SE

Questions and answers

When was Canon Auto Ref Keratometer RK-1 cleared by the FDA?

Canon Auto Ref Keratometer RK-1 (K861415) received a 510(k) decision of Substantially Equivalent on May 14, 1986, 29 days after the submission was received.