Atlas FDA

MODIFICATION TO SYSTEM 83 PLUS

FDA 510(k) clearance K983017 · decided 1998-09-22

Clearance details

K-number
K983017
Device name
MODIFICATION TO SYSTEM 83 PLUS
Applicant
Custom Ultrasonics
Decision
Substantially Equivalent
Date received
1998-08-28
Decision date
1998-09-22
Days to decision
25 days
Clearance type
Special
Product code
NVE
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Ivyland, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. recall (Z-0426-2014)Custom Ultrasonics, Inc.2013-11-27
System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc recall (Z-1182-2008)Custom Ultrasonics, Inc.2008-03-07