HEARTSINE SAMARITAN PAD 350P
FDA 510(k) clearance K123881 · decided 2013-07-11
Clearance details
- K-number
- K123881
- Device name
- HEARTSINE SAMARITAN PAD 350P
- Applicant
- Heartsine Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-17
- Decision date
- 2013-07-11
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Northern, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM recall (Z-2115-2014) | Heartsine Technologies, Limited | 2014-07-24 |