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FDA 510(k)

HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR

K-Number: K991685 · 1999-08-13

ApplicantMedic-Aid , Ltd.
Decision Date1999-08-13
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Medic-Aid , Ltd.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K991685. 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 HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR?

HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Medic-Aid , Ltd.. The 510(k) number is K991685.

When did HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR receive FDA 510(k) clearance?

HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR received FDA 510(k) clearance on 1999-08-13, under 510(k) number K991685.

Who is the listed applicant for HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR?

The FDA 510(k) record lists Medic-Aid , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR?

The FDA product code for HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR is CAF.

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Other records listing Medic-Aid , 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.

K981772HALOLITE AAD SYSTEMK971933PORT-NEBK934749FREEWAY LITE NEBULIZER COMPRESSORK940888SYSTEM 22 PAEDIATRIC MASKK940887SYSTEM 22 ADULT MASKK933535VENTSTREAM DRUG NEBULIZER

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Related Devices (Code: CAF)

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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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