FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
FDA 510(k) clearance K082641 · decided 2008-11-10
Clearance details
- K-number
- K082641
- Device name
- FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
- Applicant
- Contec Medical System Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-11
- Decision date
- 2008-11-10
- Days to decision
- 60 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Zhong Shan, Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.