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FDA 510(k)

GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM

K-Number: K120532 · 2013-05-02

ApplicantGetinge Sourcing, LLC
Decision Date2013-05-02
Product CodePEC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Getinge Sourcing, LLC. It received FDA 510(k) clearance on 2013-05-02 under 510(k) number K120532. The device is classified under product code PEC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM?

GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-02. The listed applicant is Getinge Sourcing, LLC. The 510(k) number is K120532.

When did GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM receive FDA 510(k) clearance?

GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM received FDA 510(k) clearance on 2013-05-02, under 510(k) number K120532.

Who is the listed applicant for GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM?

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

What is the FDA product code for GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM?

The FDA product code for GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM is PEC.

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Other records listing Getinge Sourcing, LLC as applicant

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.

K153713Getinge Series Warming CabinetK122625GETINGE 800HC- SERIES STEAM STERILIZERK122071GETINGE 400HC-E / SERIES STEAM STERILIZERK120441GETINGE 700HC-E SERIES STEAM STERILIZERK103504GETINGE 400HC/500HC SERIES STEAM STERILIZERK070657GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER

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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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