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FDA 510(k)

MODEL 5135 AUTO LP/FLASH

K-Number: K944607 · 1994-12-13

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1994-12-13
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL 5135 AUTO LP/FLASH is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1994-12-13 under 510(k) number K944607. The device is classified under product code GCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 5135 AUTO LP/FLASH?

MODEL 5135 AUTO LP/FLASH is a medical device that received FDA 510(k) clearance on 1994-12-13. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K944607.

When did MODEL 5135 AUTO LP/FLASH receive FDA 510(k) clearance?

MODEL 5135 AUTO LP/FLASH received FDA 510(k) clearance on 1994-12-13, under 510(k) number K944607.

Who is the listed applicant for MODEL 5135 AUTO LP/FLASH?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 5135 AUTO LP/FLASH?

The FDA product code for MODEL 5135 AUTO LP/FLASH is GCT.

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Other records listing Richard Wolf Medical Instruments Corp. as applicant

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Related Devices (Code: GCT)

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.

K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbHK082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec 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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