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FDA 510(k)

Heartland Health Surgical Mask

K-Number: K212366 · 2022-02-19

ApplicantHeartland Health Products
Decision Date2022-02-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Heartland Health Surgical Mask is a medical device manufactured by Heartland Health Products. It received FDA 510(k) clearance on 2022-02-19 under approval number K212366. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Heartland Health Surgical Mask?

Heartland Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-19. It is manufactured by Heartland Health Products. The 510(k) number is K212366.

When was Heartland Health Surgical Mask approved by the FDA?

Heartland Health Surgical Mask received FDA 510(k) clearance on 2022-02-19, under approval number K212366.

What company makes Heartland Health Surgical Mask?

Heartland Health Surgical Mask is manufactured by Heartland Health Products.

What is the FDA product code for Heartland Health Surgical Mask?

The FDA product code for Heartland Health Surgical Mask is FXX.

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Related PubMed Literature

PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Related Devices (Code: FXX)

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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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