Device product
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
Z-1908-2021
Product summary
- Event
- Event 87958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1600 units
- Official record key
device-enforcement:Z-1908-2021
Official wording
Reason: No 510k for the product to be used in a natural or surgical opening to the body
Code information: Lot Numbers: 1908E209 1908E435 2005E171 2007E030
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