Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K990416
Device Classification Name
System, Telethermographic (Adjunctive Use)
More FDA Info for this Device
510(K) Number
K990416
Device Name
System, Telethermographic (Adjunctive Use)
Applicant
OMNICORDER TECHNOLOGIES, INC.
25 EAST LOOP RD.
STONY BROOK, NY 11790-3550 US
Other 510(k) Applications for this Company
Contact
MARK FAUCI
Other 510(k) Applications for this Contact
Regulation Number
884.2980
More FDA Info for this Regulation Number
Classification Product Code
LHQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/1999
Decision Date
12/23/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact