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FDA 510(k)

NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS

K-Number: K050800 · 2005-11-23

ApplicantCaesarea Medical Electronics , Ltd.
Decision Date2005-11-23
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS is the device name listed in this FDA 510(k) record. The listed applicant is Caesarea Medical Electronics , Ltd.. It received FDA 510(k) clearance on 2005-11-23 under 510(k) number K050800. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS?

NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS is a medical device that received FDA 510(k) clearance on 2005-11-23. The listed applicant is Caesarea Medical Electronics , Ltd.. The 510(k) number is K050800.

When did NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS receive FDA 510(k) clearance?

NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS received FDA 510(k) clearance on 2005-11-23, under 510(k) number K050800.

Who is the listed applicant for NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS?

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

What is the FDA product code for NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS?

The FDA product code for NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS is FRN.

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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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