Rota System 5000

FDA 510(k) K935952 · Rota Systems Medfurniture, Inc.

Substantially Equivalent

510(k) numberK935952

Submission

Device name
Rota System 5000
Applicant
Rota Systems Medfurniture, Inc.
Derby, KS, US
Received
December 13, 1993
Decision date
April 19, 1994
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
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
K913961Ophthalmic StandHMF · Traditional Luneau Ophtalmologie SA12/04/1991SE
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
K931839Rota System XLHMF · Traditional 11/22/1993SE

Questions and answers

When was Rota System 5000 cleared by the FDA?

Rota System 5000 (K935952) received a 510(k) decision of Substantially Equivalent on April 19, 1994, 127 days after the submission was received.

What is the product code of K935952?

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