FUTREX-5000
FDA 510(k) clearance K922600 · decided 1995-12-28
Clearance details
- K-number
- K922600
- Device name
- FUTREX-5000
- Applicant
- Futrex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-02
- Decision date
- 1995-12-28
- Days to decision
- 1304 days
- Clearance type
- Traditional
- Product code
- DSB
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Gaithersburg, MD, US
- Third-party review
- No
- Expedited review
- No
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| SOZO (K172507) | ImpediMed Limited | 2017-12-22 |
Recalls involving this device
No recalls on record reference this clearance.