FC 700 FETAL MONITOR
FDA 510(k) clearance K043597 · decided 2005-12-16
Clearance details
- K-number
- K043597
- Device name
- FC 700 FETAL MONITOR
- Applicant
- Bionet Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-29
- Decision date
- 2005-12-16
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Wonju, Kwangwon-Do, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bionet Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.