FDA 510(k) Application Details - K233855

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K233855
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	Enchant Tek Co. Ltd. No. 210 Xiangzhong Rd. Dongshan Township Yilan County 26950 TW Other 510(k) Applications for this Company
Contact	Leonard Ling Other 510(k) Applications for this Contact
Regulation Number	868.5690   More FDA Info for this Regulation Number
Classification Product Code	BWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2023
Decision Date	02/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review