SENSUA!
FDA 510(k) clearance K021125 · decided 2002-10-25
Clearance details
- K-number
- K021125
- Device name
- SENSUA!
- Applicant
- Aac Consulting Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-08
- Decision date
- 2002-10-25
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.