CliniCloud Non-contact Thermometer, Model SPL1024
FDA 510(k) clearance K161325 · decided 2016-06-22
Clearance details
- K-number
- K161325
- Device name
- CliniCloud Non-contact Thermometer, Model SPL1024
- Applicant
- Stethocloud Pty.Ltd (Clinicloud)
- Decision
- Substantially Equivalent
- Date received
- 2016-05-12
- Decision date
- 2016-06-22
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Melbourne Vic, AU
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.