Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K034032
Device Classification Name
Continuous, Ventilator, Home Use
More FDA Info for this Device
510(K) Number
K034032
Device Name
Continuous, Ventilator, Home Use
Applicant
RESPIRONICS CALIFORNIA, INC.
2271 COSMOS CT.
CARLSBAD, CA 92009 US
Other 510(k) Applications for this Company
Contact
MARY FUNK
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
NOU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/29/2003
Decision Date
03/16/2004
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact