FDA 510(k) Application Details - K101262

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K101262
Device Name	Chamber, Hyperbaric
Applicant	PRESSURE-TECH, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	MARIA GRIFFIN 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	05/05/2010
Decision Date	06/10/2010
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	Y
Expedited Review