CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
FDA premarket approval P910063 · decided 1995-09-29
Approval details
- PMA number
- P910063
- Trade name
- CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
- Generic name
- Home uterine activity monitor
- Applicant
- Matria Healthcare, Inc.
- Date received
- 1991-10-21
- Decision date
- 1995-09-29
- Days to decision
- 1439 days
- Decision code
- APRL
- Product code
- LQK
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Marietta, GA
- Statement
- APPROVAL FOR CAREFONE HOME UTERINE ACTIVITY MONITORING SYSTE, MODEL 2001
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