Device product
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Z-1922-2021
Product summary
- Event
- Event 87958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36000
- Official record key
device-enforcement:Z-1922-2021
Official wording
Reason: No 510k for the product to be used in a natural or surgical opening to the body
Code information: Lot Numbers: 1910E448 2009E249 2009E248 2010E214 2011E249
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