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FDA 510(k)

ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER

K-Number: K983736 · 1998-11-10

ApplicantBrasamerica Medical Equipment, Inc.
Decision Date1998-11-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Brasamerica Medical Equipment, Inc.. It received FDA 510(k) clearance on 1998-11-10 under 510(k) number K983736. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER?

ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER is a medical device that received FDA 510(k) clearance on 1998-11-10. The listed applicant is Brasamerica Medical Equipment, Inc.. The 510(k) number is K983736.

When did ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER receive FDA 510(k) clearance?

ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER received FDA 510(k) clearance on 1998-11-10, under 510(k) number K983736.

Who is the listed applicant for ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER?

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

What is the FDA product code for ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER?

The FDA product code for ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER is CAF.

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 Brasamerica Medical Equipment, 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.

K972371ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR

Related Devices (Code: CAF)

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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