FDA 510(k) Application Details - K240569

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K240569
Device Name	Chamber, Hyperbaric
Applicant	Fink Engineering Pty Ltd 14 Premier Circuit Warana 4575 AU Other 510(k) Applications for this Company
Contact	Eric Fink Other 510(k) Applications for this Contact
Regulation Number	868.5470   More FDA Info for this Regulation Number
Classification Product Code	CBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/29/2024
Decision Date	11/21/2024
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