Atlas FDA

EasyOne Filter

FDA 510(k) clearance K221250 · decided 2022-11-22

Clearance details

K-number
K221250
Device name
EasyOne Filter
Applicant
Ndd Medizintechnik AG
Decision
Substantially Equivalent
Date received
2022-05-02
Decision date
2022-11-22
Days to decision
204 days
Clearance type
Traditional
Product code
CAH
Device class
2
Regulation number
868.5260
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Zurich, CH
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.