Device product
Pentax Video Colonoscope Model: EC38-i10L
Z-1268-2020
Product summary
- Event
- Event 84735
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1268-2020
Official wording
Reason: Distributed in the USA without an approved 510K
Code information: Serial Numbers:L110746
Distribution pattern: NC, MA
Derived failure modes
-
Unknown
Distributed in the USA without an approved 510K