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FDA 510(k)

STANDARD NEBULIZER HEATER

K-Number: K895913 · 1989-12-22

ApplicantSeamless Div., Professional Medical Products
Decision Date1989-12-22
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STANDARD NEBULIZER HEATER is the device name listed in this FDA 510(k) record. The listed applicant is Seamless Div., Professional Medical Products. It received FDA 510(k) clearance on 1989-12-22 under 510(k) number K895913. 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 STANDARD NEBULIZER HEATER?

STANDARD NEBULIZER HEATER is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Seamless Div., Professional Medical Products. The 510(k) number is K895913.

When did STANDARD NEBULIZER HEATER receive FDA 510(k) clearance?

STANDARD NEBULIZER HEATER received FDA 510(k) clearance on 1989-12-22, under 510(k) number K895913.

Who is the listed applicant for STANDARD NEBULIZER HEATER?

The FDA 510(k) record lists Seamless Div., Professional Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANDARD NEBULIZER HEATER?

The FDA product code for STANDARD NEBULIZER HEATER is CAF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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