PD-1400 PACER/DEFIBRILLATOR
FDA 510(k) clearance K932028 · decided 1993-10-08
Clearance details
- K-number
- K932028
- Device name
- PD-1400 PACER/DEFIBRILLATOR
- Applicant
- Zoll Medical Corp
- Decision
- Substantially Equivalent
- Date received
- 1993-04-26
- Decision date
- 1993-10-08
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.