COMPASS COMPRESSION ASSIST HANDLE
FDA 510(k) clearance K053398 · decided 2006-03-10
Clearance details
- K-number
- K053398
- Device name
- COMPASS COMPRESSION ASSIST HANDLE
- Applicant
- Semler Technologies, Inc. Dba
- Decision
- Substantially Equivalent
- Date received
- 2005-12-06
- Decision date
- 2006-03-10
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.