POWER INFUSER, MODEL M100B-3A
FDA 510(k) clearance K090736 · decided 2009-05-20
Clearance details
- K-number
- K090736
- Device name
- POWER INFUSER, MODEL M100B-3A
- Applicant
- ZOLL Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-03-19
- Decision date
- 2009-05-20
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Chelmsford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
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