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FDA 510(k)

GAS STERILIZATION EQUIPMENT

K-Number: K821842 · 1982-07-28

ApplicantGetinge International, Inc.
Decision Date1982-07-28
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GAS STERILIZATION EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Getinge International, Inc.. It received FDA 510(k) clearance on 1982-07-28 under 510(k) number K821842. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAS STERILIZATION EQUIPMENT?

GAS STERILIZATION EQUIPMENT is a medical device that received FDA 510(k) clearance on 1982-07-28. The listed applicant is Getinge International, Inc.. The 510(k) number is K821842.

When did GAS STERILIZATION EQUIPMENT receive FDA 510(k) clearance?

GAS STERILIZATION EQUIPMENT received FDA 510(k) clearance on 1982-07-28, under 510(k) number K821842.

Who is the listed applicant for GAS STERILIZATION EQUIPMENT?

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

What is the FDA product code for GAS STERILIZATION EQUIPMENT?

The FDA product code for GAS STERILIZATION EQUIPMENT is FLF.

Related Clinical Trials

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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Other records listing Getinge International, Inc. 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.

K920413DECOMAT A 8666K920406DECOMAT 228K821591STEAM STERILIZATION EQUIPMENT

Related Devices (Code: FLF)

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.

K192978EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.K090636TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.K051595TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.K020875TSO3 OZONE STERILIZER, MODEL 125LTechnologies of Sterilization With Oxone, Tso3, Inc.K014013H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEMH & W Technology, LLC

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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