Ophthalmic Stand

FDA 510(k) K913961 · Luneau Ophtalmologie SA

Substantially Equivalent

510(k) numberK913961

Submission

Device name
Ophthalmic Stand
Applicant
Luneau Ophtalmologie SA
Chartres Cedex, FR
Received
September 5, 1991
Decision date
December 4, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HMF – Stand, Instrument, Ac-Powered, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.1860
Specialty
Ophthalmic

Other 510(k)s with product code HMF

510(k)DeviceApplicantDecision
K935952Rota System 5000HMF · Traditional Rota Systems Medfurniture, Inc.04/19/1994SE
K935945Rota Datamate IHMF · Traditional Rota Systems,Inc.04/19/1994SE
K931839Rota System XLHMF · Traditional Rota Systems Medfurniture, Inc.11/22/1993SE
K930440Marco International StandHMF · Traditional Marco Ophthalmic, Inc.07/06/1993SE
K924780Burton Ophthalmic Exam Unit - Model 2201HMF · Traditional R.H. Burton Co.04/05/1993SE
K924771Burton Ophthalmic Stand - Model XL3200HMF · Traditional R.H. Burton Co.04/05/1993SE
K853358Reliance Pendulum Ophthalmic Delivery SystemHMF · Traditional Dentsply Intl.10/04/1985SE
K844362Ophthalmic ChairHMF · Traditional Luneau Laboratories12/11/1984SE
K844363Ophthalmic StandHMF · Traditional Luneau Laboratories12/05/1984SE
K832073Electric Instrument TableHMF · Traditional CooperVision, Inc.08/12/1983SE

More from CooperVision, Inc.

510(k)DeviceDecision
K922253Keratoref L60HLQ · Traditional 06/19/1992SE
K921214Ophthalmic ProjectorHOS · Traditional 06/11/1992SE

Questions and answers

When was Ophthalmic Stand cleared by the FDA?

Ophthalmic Stand (K913961) received a 510(k) decision of Substantially Equivalent on December 4, 1991, 90 days after the submission was received.

What is the product code of K913961?

The FDA product code is HMF – Stand, Instrument, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1860.