Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K011597
Device Classification Name
Monitor, Apnea, Facility Use
More FDA Info for this Device
510(K) Number
K011597
Device Name
Monitor, Apnea, Facility Use
Applicant
RESPIRONICS GEORGIA, INC.
175 CHASTAIN MEADOWS COURT
KENNESAW, GA 30144 US
Other 510(k) Applications for this Company
Contact
BETSY CORTELLONI
Other 510(k) Applications for this Contact
Regulation Number
868.2377
More FDA Info for this Regulation Number
Classification Product Code
FLS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/24/2001
Decision Date
01/11/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact