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FDA 510(k)

INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456

K-Number: K042655 · 2004-10-13

ApplicantRespironics New Jersey, Inc.
Decision Date2004-10-13
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics New Jersey, Inc.. It received FDA 510(k) clearance on 2004-10-13 under 510(k) number K042655. 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 INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456?

INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 is a medical device that received FDA 510(k) clearance on 2004-10-13. The listed applicant is Respironics New Jersey, Inc.. The 510(k) number is K042655.

When did INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 receive FDA 510(k) clearance?

INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 received FDA 510(k) clearance on 2004-10-13, under 510(k) number K042655.

Who is the listed applicant for INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456?

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

What is the FDA product code for INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456?

The FDA product code for INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 is CAF.

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Other records listing Respironics New Jersey, Inc. as applicant

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Official Source

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