FDA 510(k) Application Details - K990574

Device Classification Name Ventilator, Continuous, Minimal Ventilatory Support,Facility Use

  More FDA Info for this Device
510(K) Number K990574
Device Name Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
Other 510(k) Applications for this Company
Contact DAVID J VANELLA
Other 510(k) Applications for this Contact
Regulation Number 868.5895

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

  More FDA Info for this Product Code
Date Received 02/23/1999
Decision Date 05/24/1999
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee AN - Anesthesiology
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