PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE— 510(k) K974036
Substantially EquivalentThe Prometheus Group
FDA 510(k) clearance K974036 for PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE, Substantially Equivalent on 1997-12-22. Applicant: The Prometheus Group. Device class: 2.
Clearance details
- Applicant
- The Prometheus Group
- Product code
- Code HIR
- Device class
- Class 2
- Regulation
- 21 CFR 884.1425
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Duxbury, MA, US
Recent devices under product code HIR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.