MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
FDA 510(k) clearance K061857 · decided 2006-08-01
Clearance details
- K-number
- K061857
- Device name
- MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
- Applicant
- Bio Compression Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-30
- Decision date
- 2006-08-01
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Broadview Heights, OH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.