HEARTSINE SAMARITAN PAD
FDA 510(k) clearance K041067 · decided 2004-05-25
Clearance details
- K-number
- K041067
- Device name
- HEARTSINE SAMARITAN PAD
- Applicant
- Heartsine Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-23
- Decision date
- 2004-05-25
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; recall (Z-0124-2013) | Heartsine Technologies, Limited | 2012-10-27 |