SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
FDA 510(k) clearance K073147 · decided 2007-12-03
Clearance details
- K-number
- K073147
- Device name
- SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
- Applicant
- Transoma Medical
- Decision
- Substantially Equivalent
- Date received
- 2007-11-08
- Decision date
- 2007-12-03
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- MXC
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arden Hills, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.