INFUSION DYNAMICS POWER INFUSER MODEL M100B
FDA 510(k) clearance K992044 · decided 1999-09-08
Clearance details
- K-number
- K992044
- Device name
- INFUSION DYNAMICS POWER INFUSER MODEL M100B
- Applicant
- Infusion Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-17
- Decision date
- 1999-09-08
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infusion Dynamics Power Infuser pump. Model number M100B-3A recall (Z-0062-05) | Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics | 2004-11-02 |