MODEL PC-860 FETAL DOPPLER
FDA 510(k) clearance K082055 · decided 2009-02-06
Clearance details
- K-number
- K082055
- Device name
- MODEL PC-860 FETAL DOPPLER
- Applicant
- Shenzhen Creative Industry Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-21
- Decision date
- 2009-02-06
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- KNG
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chenzhen City, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.