Device product
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
Z-1921-2021
Product summary
- Event
- Event 87958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33250 units
- Official record key
device-enforcement:Z-1921-2021
Official wording
Reason: No 510k for the product to be used in a natural or surgical opening to the body
Code information: Lot Numbers: 2008E475 2009E247 2010E217 2012E102 2012E191
Distribution pattern: US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Derived failure modes
-
Unknown
No 510k for the product to be used in a natural or surgical opening to the body