BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
FDA 510(k) clearance K941921 · decided 1994-07-20
Clearance details
- K-number
- K941921
- Device name
- BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
- Applicant
- Medtronic Bio-Medicus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-20
- Decision date
- 1994-07-20
- Days to decision
- 91 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
| Record | Firm | Date |
|---|---|---|
| Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufact recall (Z-1939-2010) | Medtronic Cardiovascular Revascularization & Surgical Therap | 2010-06-30 |