BIO BOOST— 510(k) K961426
Substantially EquivalentBio Compression Systems, Inc.
FDA 510(k) clearance K961426 for BIO BOOST, Substantially Equivalent on 1996-10-28. Applicant: Bio Compression Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Compression Systems, Inc.
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Broadview Heights, OH, US
Recent devices under product code IRP
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view all- K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)
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- K213533 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K210417 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K180248 — VascuEase IC-1200-WH
Data sourced from openFDA. This site is unofficial and independent of the FDA.