Nordiwell Surgical Face Mask
K-Number: K210181 · 2021-03-09
Decision Date2021-03-09
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Nordiwell Surgical Face Mask is a medical device manufactured by Changzhou Combat Protective Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-03-09 under approval number K210181. 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 Nordiwell Surgical Face Mask?
Nordiwell Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-09. It is manufactured by Changzhou Combat Protective Equipment Co., Ltd.. The 510(k) number is K210181.
When was Nordiwell Surgical Face Mask approved by the FDA?
Nordiwell Surgical Face Mask received FDA 510(k) clearance on 2021-03-09, under approval number K210181.
What company makes Nordiwell Surgical Face Mask?
Nordiwell Surgical Face Mask is manufactured by Changzhou Combat Protective Equipment Co., Ltd..
What is the FDA product code for Nordiwell Surgical Face Mask?
The FDA product code for Nordiwell Surgical Face Mask is FXX.
Other Devices by Changzhou Combat Protective Equipment Co., Ltd.
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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.