CARE ZY5BA OXYGEN CONCENTRATOR
FDA 510(k) clearance K102245 · decided 2010-11-09
Clearance details
- K-number
- K102245
- Device name
- CARE ZY5BA OXYGEN CONCENTRATOR
- Applicant
- Foshan Care Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-09
- Decision date
- 2010-11-09
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Nanshan, Shenzhen, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.