Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K202142
Device Classification Name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K202142
Device Name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 US
Other 510(k) Applications for this Company
Contact
Jonquil Mau
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2020
Decision Date
10/29/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact