SubtlePET— 510(k) K182336
Substantially EquivalentSubtle Medical, Inc.
FDA 510(k) clearance K182336 for SubtlePET, Substantially Equivalent on 2018-11-30. Applicant: Subtle Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Subtle Medical, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code KPS
view allMore clearances from Subtle Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.