510(k) K242272
K242272 is an FDA 510(k) premarket notification submitted by Blue Belt Technologies, Inc. for the device "CORIOGRAPH Pre-Op Planning and Modeling Services". The FDA issued a decision of Substantially Equivalent on November 15, 2024. Blue Belt Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2024
- Date Received
- August 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No