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FDA 510(k)

TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE

K-Number: K063681 · 2007-06-29

ApplicantMediline Italia S.R.L.
Decision Date2007-06-29
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Mediline Italia S.R.L.. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K063681. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE?

TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Mediline Italia S.R.L.. The 510(k) number is K063681.

When did TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE receive FDA 510(k) clearance?

TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE received FDA 510(k) clearance on 2007-06-29, under 510(k) number K063681.

Who is the listed applicant for TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE?

The FDA 510(k) record lists Mediline Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE?

The FDA product code for TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE is FLE.

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Related Devices (Code: FLE)

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.

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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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