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FDA 510(k)

AEROSOL-T

K-Number: K863318 · 1986-09-11

ApplicantSouthmedic, Inc.
Decision Date1986-09-11
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROSOL-T is the device name listed in this FDA 510(k) record. The listed applicant is Southmedic, Inc.. It received FDA 510(k) clearance on 1986-09-11 under 510(k) number K863318. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROSOL-T?

AEROSOL-T is a medical device that received FDA 510(k) clearance on 1986-09-11. The listed applicant is Southmedic, Inc.. The 510(k) number is K863318.

When did AEROSOL-T receive FDA 510(k) clearance?

AEROSOL-T received FDA 510(k) clearance on 1986-09-11, under 510(k) number K863318.

Who is the listed applicant for AEROSOL-T?

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

What is the FDA product code for AEROSOL-T?

The FDA product code for AEROSOL-T is BZA.

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Other records listing Southmedic, 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.

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Related Devices (Code: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, 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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