COROMETRICS MODEL 171 AND 172 FETAL MONITOR
FDA 510(k) clearance K991905 · decided 1999-09-01
Clearance details
- K-number
- K991905
- Device name
- COROMETRICS MODEL 171 AND 172 FETAL MONITOR
- Applicant
- General Electric Medical Systems Information Techn
- Decision
- Substantially Equivalent
- Date received
- 1999-06-04
- Decision date
- 1999-09-01
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.