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FDA 510(k)

STERI-VAC(TM) AERATOR MODEL XL

K-Number: K904921 · 1990-12-05

Applicant3M Health Care, Ltd.
Decision Date1990-12-05
Product CodeFLI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERI-VAC(TM) AERATOR MODEL XL is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Ltd.. It received FDA 510(k) clearance on 1990-12-05 under 510(k) number K904921. The device is classified under product code FLI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERI-VAC(TM) AERATOR MODEL XL?

STERI-VAC(TM) AERATOR MODEL XL is a medical device that received FDA 510(k) clearance on 1990-12-05. The listed applicant is 3M Health Care, Ltd.. The 510(k) number is K904921.

When did STERI-VAC(TM) AERATOR MODEL XL receive FDA 510(k) clearance?

STERI-VAC(TM) AERATOR MODEL XL received FDA 510(k) clearance on 1990-12-05, under 510(k) number K904921.

Who is the listed applicant for STERI-VAC(TM) AERATOR MODEL XL?

The FDA 510(k) record lists 3M Health Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERI-VAC(TM) AERATOR MODEL XL?

The FDA product code for STERI-VAC(TM) AERATOR MODEL XL is FLI.

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Other records listing 3M Health Care, Ltd. 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.

K953904SARNS 9000 UNIVERSAL ROLLER PUMPK926364ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129XK941534MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEMK941748STERI-VAC GAS STERILIZER MODEL 8XLK9306813M PREVENTION FABRIC SURGICAL GOWN #78XXK9323073M MAXI-DRIVER II DBATTERY POWERED SYSTEM

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Related Devices (Code: FLI)

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.

K902906GAS-VAK(R) COMBINATION STERILIZER & VENTILATORGas-VakK831595CASTLE MODEL 3341 & 3441 & 4141 GAS AERCastle Co.K830165BEAR JET 150 VENTILATORBear Medical Systems, Inc.K813201CASTLE #3241 GAS AERATORSybron Corp.K790677EO EVACUATING SYSTEM ICastle Co.K781484CASTLE MODEL 3146 GAS AERATORCastle Co.

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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