MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
FDA 510(k) clearance K924206 · decided 1993-05-07
Clearance details
- K-number
- K924206
- Device name
- MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
- Applicant
- Medtronic Bio-Medicus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-20
- Decision date
- 1993-05-07
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- DWA
- Device class
- 2
- Regulation number
- 870.4380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.