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FDA 510(k)

MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER

K-Number: K031259 · 2003-05-12

ApplicantGetinge USA, Inc.
Decision Date2003-05-12
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Getinge USA, Inc.. It received FDA 510(k) clearance on 2003-05-12 under 510(k) number K031259. 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 MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER?

MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER is a medical device that received FDA 510(k) clearance on 2003-05-12. The listed applicant is Getinge USA, Inc.. The 510(k) number is K031259.

When did MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER receive FDA 510(k) clearance?

MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER received FDA 510(k) clearance on 2003-05-12, under 510(k) number K031259.

Who is the listed applicant for MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER?

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

What is the FDA product code for MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER?

The FDA product code for MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER 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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