FDA 510(k) Application Details - K243603

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K243603
Device Name	Recorder, Magnetic Tape, Medical
Applicant	Aevice Health Pte. Ltd. 18 Howard Road, #06-11 Novelty Bizcentre Singapore 369585 SG Other 510(k) Applications for this Company
Contact	Adrian Ang Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	DSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2024
Decision Date	05/05/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review