Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K200986
Device Classification Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
More FDA Info for this Device
510(K) Number
K200986
Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant
OPTI Medical Systems, Inc.
235 Hembree Park Drive
Roswell, GA 30114 US
Other 510(k) Applications for this Company
Contact
Theron Gober
Other 510(k) Applications for this Contact
Regulation Number
862.1120
More FDA Info for this Regulation Number
Classification Product Code
CHL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/15/2020
Decision Date
08/02/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact