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FDA 510(k)

AEROSTAR

K-Number: K921313 · 1992-09-11

ApplicantBiosafety Systems, Inc.
Decision Date1992-09-11
Product CodeCBN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROSTAR is the device name listed in this FDA 510(k) record. The listed applicant is Biosafety Systems, Inc.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K921313. The device is classified under product code CBN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROSTAR?

AEROSTAR is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is Biosafety Systems, Inc.. The 510(k) number is K921313.

When did AEROSTAR receive FDA 510(k) clearance?

AEROSTAR received FDA 510(k) clearance on 1992-09-11, under 510(k) number K921313.

Who is the listed applicant for AEROSTAR?

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

What is the FDA product code for AEROSTAR?

The FDA product code for AEROSTAR is CBN.

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Other records listing Biosafety Systems, 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.

K952274CHEMOGUARD, P2 HIRISKK944514P2 NITRILE EXAM GLOVESK944142P2 EXAM GLOVESK944095P2 NITRILE EXAM GLOVESK904130CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL)K901411CHEMOPLUS GLOVE

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Related Devices (Code: CBN)

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.

K223452Nitronox Scavenger PlusParker Hannifin CorporationK193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.K160950MINISCAVSedation Systems, LLCK123176ISO-GARD CLEARAIR MASKTeleflexmedical, Inc.K110930ACTIVE WASTE GAS SCAVENGERG. Dundas Co.,Inc.K092031VAPOR-CLEAR, MODEL 100Axon Medical, Inc.

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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