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FDA 510(k)

NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1

K-Number: K121007 · 2012-12-28

ApplicantDelta Med Srl
Decision Date2012-12-28
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 is the device name listed in this FDA 510(k) record. The listed applicant is Delta Med Srl. It received FDA 510(k) clearance on 2012-12-28 under 510(k) number K121007. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1?

NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 is a medical device that received FDA 510(k) clearance on 2012-12-28. The listed applicant is Delta Med Srl. The 510(k) number is K121007.

When did NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 receive FDA 510(k) clearance?

NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 received FDA 510(k) clearance on 2012-12-28, under 510(k) number K121007.

Who is the listed applicant for NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1?

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

What is the FDA product code for NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1?

The FDA product code for NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 is FOZ.

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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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