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FDA 510(k)

BIOJET

K-Number: K122329 · 2012-08-16

ApplicantJet Soft Srl
Decision Date2012-08-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOJET is the device name listed in this FDA 510(k) record. The listed applicant is Jet Soft Srl. It received FDA 510(k) clearance on 2012-08-16 under 510(k) number K122329. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOJET?

BIOJET is a medical device that received FDA 510(k) clearance on 2012-08-16. The listed applicant is Jet Soft Srl. The 510(k) number is K122329.

When did BIOJET receive FDA 510(k) clearance?

BIOJET received FDA 510(k) clearance on 2012-08-16, under 510(k) number K122329.

Who is the listed applicant for BIOJET?

The FDA 510(k) record lists Jet Soft Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOJET?

The FDA product code for BIOJET is LLZ.

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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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