FDA.report

Product code MOA

Device name
Analyzer, Diagnostic, Fiber Optic (Colon)
Medical specialty
Unknown
Device class
3
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Source
FDA openFDA device classification dataset

Related PMA Records

PMADeviceApplicantDecision date
P990050S007WAVSTAT OPTICAL BIOPSY SYSTEMSPECTRA SCIENCE2009-08-27
P990050S006WAVSTAT OPTICAL BIOPSY SYSTEMSPECTRA SCIENCE2006-03-28
P990050S005WAVSTAT OPTICAL BIOPSY SYSTEMSPECTRA SCIENCE2002-08-06
P990050S004WAVSTAT OPTICAL BIOPSY SYSTEMSPECTRA SCIENCE2002-06-14
P990050S003WAVSTAT (TM) OPTICAL BIOPSY SYSTEMSPECTRA SCIENCE2001-11-28
P990050S002WAVSTAT OPTICAL BIOPSY SYTEMSPECTRA SCIENCE2001-08-17
P990050S001OPTICAL BIOPSY(TM) SYSTEMSPECTRA SCIENCE2001-02-16
P990050OPTICAL BIOPSY(TM) SYSTEMSPECTRA SCIENCE2000-11-14