Nordiwell Medical Face Mask
K-Number: K202615 · 2020-12-31
Decision Date2020-12-31
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Nordiwell Medical Face Mask is a medical device manufactured by Changzhou Combat Protective Equipment Co., Ltd.. It received FDA 510(k) clearance on 2020-12-31 under approval number K202615. 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 Medical Face Mask?
Nordiwell Medical Face Mask is a medical device that received FDA 510(k) clearance on 2020-12-31. It is manufactured by Changzhou Combat Protective Equipment Co., Ltd.. The 510(k) number is K202615.
When was Nordiwell Medical Face Mask approved by the FDA?
Nordiwell Medical Face Mask received FDA 510(k) clearance on 2020-12-31, under approval number K202615.
What company makes Nordiwell Medical Face Mask?
Nordiwell Medical Face Mask is manufactured by Changzhou Combat Protective Equipment Co., Ltd..
What is the FDA product code for Nordiwell Medical Face Mask?
The FDA product code for Nordiwell Medical 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.