HEARTSTART 2000 DEFIBRILLATION ELECTRODE
FDA 510(k) clearance K885186 · decided 1989-02-23
Clearance details
- K-number
- K885186
- Device name
- HEARTSTART 2000 DEFIBRILLATION ELECTRODE
- Applicant
- Laerdal Mfg. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-14
- Decision date
- 1989-02-23
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.