EUM 100Pro
FDA 510(k) clearance K150398 · decided 2015-08-06
Clearance details
- K-number
- K150398
- Device name
- EUM 100Pro
- Applicant
- Ob Tools, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-18
- Decision date
- 2015-08-06
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Migdal Ha-Emek, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.