TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
FDA 510(k) clearance K102191 · decided 2011-05-02
Clearance details
- K-number
- K102191
- Device name
- TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
- Applicant
- Zhongshan Transtek Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-03
- Decision date
- 2011-05-02
- Days to decision
- 272 days
- Clearance type
- Abbreviated
- 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
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Recalls involving this device
No recalls on record reference this clearance.