Device product
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Z-1914-2021
Product summary
- Event
- Event 87958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 129600 units
- Official record key
device-enforcement:Z-1914-2021
Official wording
Reason: No 510k for the product to be used in a natural or surgical opening to the body
Code information: Lot Numbers: 1906E228 1907E501 1908E562 1910E027 1910E345 1911E263 1912E541 2003E241 2003E830 2010E342 2011E403
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