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FDA 510(k)

ENERGETIC HI-HUM AERSOL UNIT

K-Number: K831162 · 1983-05-09

ApplicantEnergetic Pulmonary
Decision Date1983-05-09
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENERGETIC HI-HUM AERSOL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Energetic Pulmonary. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831162. 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 ENERGETIC HI-HUM AERSOL UNIT?

ENERGETIC HI-HUM AERSOL UNIT is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Energetic Pulmonary. The 510(k) number is K831162.

When did ENERGETIC HI-HUM AERSOL UNIT receive FDA 510(k) clearance?

ENERGETIC HI-HUM AERSOL UNIT received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831162.

Who is the listed applicant for ENERGETIC HI-HUM AERSOL UNIT?

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

What is the FDA product code for ENERGETIC HI-HUM AERSOL UNIT?

The FDA product code for ENERGETIC HI-HUM AERSOL UNIT is CAF.

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Official Source

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