MICROMED PD-8K INSULATION DEFECT DETECTOR
FDA 510(k) clearance K101606 · decided 2010-10-01
Clearance details
- K-number
- K101606
- Device name
- MICROMED PD-8K INSULATION DEFECT DETECTOR
- Applicant
- Mcgan Technology, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-06-08
- Decision date
- 2010-10-01
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- HFG
- Device class
- 2
- Regulation number
- 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Middletown, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.