FDA 510(k)
Unknown
🇺🇸 United States
Syncron-E
K Number: DEN250025
·
Decision Jun 18, 2026
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
1
Review Days
360
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Basic Information
- Device Name
- Syncron-E
- K Number
- DEN250025
- Clearance Type
- Direct
- Decision
- Unknown
- Applicant
- Autonomous Healthcare, Inc.
- Date Received
- June 23, 2025
- Decision Date
- June 18, 2026
- Product Code
- QVC
- Advisory Committee
- Unknown
- Review Advisory Committee
- AN
- Third Party
- N