TRANSTEK
FDA 510(k) clearance K112932 · decided 2011-11-01
Clearance details
- K-number
- K112932
- Device name
- TRANSTEK
- Applicant
- Zhongshan Transtek Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-03
- Decision date
- 2011-11-01
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MNW
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chengdu, Sichuan, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zhongshan Transtek Electronics 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.