Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
FDA 510(k) clearance K253162 · decided 2026-06-05
Clearance details
- K-number
- K253162
- Device name
- Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
- Applicant
- Unimed Medical Supplies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-26
- Decision date
- 2026-06-05
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.