MIRI TL
FDA 510(k) clearance K151357 · decided 2016-04-22
Clearance details
- K-number
- K151357
- Device name
- MIRI TL
- Applicant
- At Medical Uab
- Decision
- Substantially Equivalent
- Date received
- 2015-05-20
- Decision date
- 2016-04-22
- Days to decision
- 338 days
- Clearance type
- Traditional
- Product code
- MQG
- Device class
- 2
- Regulation number
- 884.6120
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Kaunas, LT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.