Atlas FDA

DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES

FDA 510(k) clearance K914145 · decided 1994-02-22

Clearance details

K-number
K914145
Device name
DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES
Applicant
Medivators, Inc.
Decision
Substantially Equivalent
Date received
1991-09-16
Decision date
1994-02-22
Days to decision
890 days
Clearance type
Traditional
Product code
FEB
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup ( recall (Z-2213-2010)Minntech Corp2010-08-12