IBT MODEL SVI
FDA 510(k) clearance K921821 · decided 1992-11-02
Clearance details
- K-number
- K921821
- Device name
- IBT MODEL SVI
- Applicant
- Biomagnetic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-16
- Decision date
- 1992-11-02
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Newhope, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.