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FDA 510(k)

LITEGUARD 9

K-Number: K851924 · 1985-08-06

ApplicantTemtech , Ltd.
Decision Date1985-08-06
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LITEGUARD 9 is the device name listed in this FDA 510(k) record. The listed applicant is Temtech , Ltd.. It received FDA 510(k) clearance on 1985-08-06 under 510(k) number K851924. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITEGUARD 9?

LITEGUARD 9 is a medical device that received FDA 510(k) clearance on 1985-08-06. The listed applicant is Temtech , Ltd.. The 510(k) number is K851924.

When did LITEGUARD 9 receive FDA 510(k) clearance?

LITEGUARD 9 received FDA 510(k) clearance on 1985-08-06, under 510(k) number K851924.

Who is the listed applicant for LITEGUARD 9?

The FDA 510(k) record lists Temtech , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LITEGUARD 9?

The FDA product code for LITEGUARD 9 is LDD.

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Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, Inc.

Official Source

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

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