FDA 510(k) Application Details - K854769

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

  More FDA Info for this Device
510(K) Number K854769
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant P.A. MCCAULEY, INC.
292 PAM LANE
MARIETTA, GA US
Other 510(k) Applications for this Company
Contact PATRICIA A MCCAULEY
Other 510(k) Applications for this Contact
Regulation Number 868.5330

  More FDA Info for this Regulation Number
Classification Product Code BZR
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/27/1985
Decision Date 06/05/1986
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact