CALM CURVE, VERSION 01.00
FDA 510(k) clearance K052715 · decided 2005-12-22
Clearance details
- K-number
- K052715
- Device name
- CALM CURVE, VERSION 01.00
- Applicant
- Lms Medical Systems (Canada), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-29
- Decision date
- 2005-12-22
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Montreal, Qc, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.