Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
FDA 510(k) clearance K150953 · decided 2015-07-16
Clearance details
- K-number
- K150953
- Device name
- Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
- Applicant
- Bio Compression Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-09
- Decision date
- 2015-07-16
- Days to decision
- 98 days
- Clearance type
- Special
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Moonachie, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.