Sterile Disposable Temperature Probe
FDA 510(k) clearance K212945 · decided 2022-03-01
Clearance details
- K-number
- K212945
- Device name
- Sterile Disposable Temperature Probe
- Applicant
- Shenzhen Envisen Industry Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-15
- Decision date
- 2022-03-01
- Days to decision
- 167 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
+ Add to Predicate Builder ◉ Watch Shenzhen Envisen Industry Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.