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FDA 510(k)

BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100

K-Number: K990435 · 2000-06-05

ApplicantApex Medical Corp.
Decision Date2000-06-05
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 2000-06-05 under 510(k) number K990435. 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 BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100?

BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 is a medical device that received FDA 510(k) clearance on 2000-06-05. The listed applicant is Apex Medical Corp.. The 510(k) number is K990435.

When did BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 receive FDA 510(k) clearance?

BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 received FDA 510(k) clearance on 2000-06-05, under 510(k) number K990435.

Who is the listed applicant for BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100?

The FDA 510(k) record lists Apex Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100?

The FDA product code for BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 is CAF.

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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

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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