INSULCLOCK® v2.0 PRO
FDA 510(k) clearance K241803 · decided 2024-08-22
Clearance details
- K-number
- K241803
- Device name
- INSULCLOCK® v2.0 PRO
- Applicant
- Insulcloud S.L.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-21
- Decision date
- 2024-08-22
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- QOG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bibao, ES
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.