Qlicksmart BladeFlask UNIVERSAL
FDA 510(k) clearance K213274 · decided 2022-06-22
Clearance details
- K-number
- K213274
- Device name
- Qlicksmart BladeFlask UNIVERSAL
- Applicant
- Qlicksmart Pty , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-30
- Decision date
- 2022-06-22
- Days to decision
- 265 days
- Clearance type
- Abbreviated
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Brisbane, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.