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510(k) K921214

Device
OPHTHALMIC PROJECTOR
Applicant
LUNEAU OPHTALMOLOGIE SA
510(k) number
K921214
Product code
HOS  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-11
Date received
1992-03-13
Regulation
886.1680
Classification name
Projector, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
YOUNG
Address
Bp 252 Chartres Cedex FR 28005 28005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K936200WIRELESS CHART PROJECTOR,HCP-W 721Canon USA, Inc.1994-09-28
K930443MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJEMarco Ophthalmic, Inc.1993-07-06
K924784BURTON PROJECTOR HEAD - MODEL 6000-HR.H. Burton Co.1993-04-05
K890992WOODLYN OPHTHALMIC PROJECTORWoodlyn, Inc.1989-05-17
K862519BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTORBausch & Lomb, Inc.1986-07-23
K812706MILLER/NADLER GLARE TESTERMosebach Electric & Supply1981-11-16
K811180ULTRAMATIC PROJECT-O-CHART OPHTH. PROJAmerican Optical Corp.1981-05-15
K781658PROJECTOR, ACCU-CHART ACUITYBausch & Lomb, Inc.1978-10-17

Legacy Summary#

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FDA Review#

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