MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
FDA 510(k) clearance K910754 · decided 1991-05-08
Clearance details
- K-number
- K910754
- Device name
- MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
- Applicant
- Hewlett-Packard Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-11
- Decision date
- 1991-05-08
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mcminnville, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.