HANDHELD PULSE OXIMETER
FDA 510(k) clearance K111494 · decided 2012-01-18
Clearance details
- K-number
- K111494
- Device name
- HANDHELD PULSE OXIMETER
- Applicant
- Beijing Choice Electronic Technololgy Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-31
- Decision date
- 2012-01-18
- Days to decision
- 232 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shijingshan District, Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.