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FDA 510(k)

Sterile Water for Inhalation in 1L Flexoval ® bottles.

K-Number: K223551 · 2023-08-03

ApplicantHometa, Inc.
Decision Date2023-08-03
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sterile Water for Inhalation in 1L Flexoval ® bottles. is a medical device manufactured by Hometa, Inc.. It received FDA 510(k) clearance on 2023-08-03 under approval number K223551. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Water for Inhalation in 1L Flexoval ® bottles.?

Sterile Water for Inhalation in 1L Flexoval ® bottles. is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Hometa, Inc.. The 510(k) number is K223551.

When was Sterile Water for Inhalation in 1L Flexoval ® bottles. approved by the FDA?

Sterile Water for Inhalation in 1L Flexoval ® bottles. received FDA 510(k) clearance on 2023-08-03, under approval number K223551.

What company makes Sterile Water for Inhalation in 1L Flexoval ® bottles.?

Sterile Water for Inhalation in 1L Flexoval ® bottles. is manufactured by Hometa, Inc..

What is the FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles.?

The FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles. is BTT.

Related Devices (Code: BTT)

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Official Source

View on FDA Database →

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