Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL— 510(k) K213533
Substantially EquivalentBio Compression Systems, Inc.
FDA 510(k) clearance K213533 for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL, Substantially Equivalent on 2022-02-16. 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
- Moonachie, NJ, US
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