PeriCALM Patterns 3.0
FDA 510(k) clearance K241009 · decided 2025-01-10
Clearance details
- K-number
- K241009
- Device name
- PeriCALM Patterns 3.0
- Applicant
- Perigen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-12
- Decision date
- 2025-01-10
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Rishon Letziyon, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.