Devon 52 Sequential Compression Device
FDA 510(k) clearance K182150 · decided 2018-12-18
Clearance details
- K-number
- K182150
- Device name
- Devon 52 Sequential Compression Device
- Applicant
- Devon Medical Products (Jiangsu), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-08
- Decision date
- 2018-12-18
- Days to decision
- 132 days
- Clearance type
- Special
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nantong, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.