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FDA 510(k)

PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500

K-Number: K070287 · 2007-02-12

ApplicantPhotonic Optische Gerate GmbH & Cokg
Decision Date2007-02-12
Product CodeEBA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 is the device name listed in this FDA 510(k) record. The listed applicant is Photonic Optische Gerate GmbH & Cokg. It received FDA 510(k) clearance on 2007-02-12 under 510(k) number K070287. The device is classified under product code EBA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500?

PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 is a medical device that received FDA 510(k) clearance on 2007-02-12. The listed applicant is Photonic Optische Gerate GmbH & Cokg. The 510(k) number is K070287.

When did PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 receive FDA 510(k) clearance?

PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 received FDA 510(k) clearance on 2007-02-12, under 510(k) number K070287.

Who is the listed applicant for PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500?

The FDA 510(k) record lists Photonic Optische Gerate GmbH & Cokg as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500?

The FDA product code for PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 is EBA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EBA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K923949SYLVAN DENTAL HEADLIGHT SYSTEMSylvan Medical FiberopticsK893458FIBEROPTIC HEADLIGHT SYSTEMCuda Products Co.K854646VEGA DENTAL OPERATING LIGHTAlpine Dental Equipment Co.K842515SURGICAL HEADLIGHTGood-Lite Co.K842358ISOLIGHTPlanmeca USA, Inc.K822265FIBEROPTIC LIGHT SOURCE W/RELATED ITEMSKelleher Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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