M3 MONITOR
FDA 510(k) clearance K091908 · decided 2009-07-10
Clearance details
- K-number
- K091908
- Device name
- M3 MONITOR
- Applicant
- Spectrum Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-25
- Decision date
- 2009-07-10
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DRY
- Device class
- 2
- Regulation number
- 870.4330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Gloucester, Gloucesterhsire, GB
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin recall (Z-2056-2017) | Zimmer Biomet, Inc. | 2017-04-25 |