Product code HEL— Obstetrics/Gynecology
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
- Classification name
- Monitor, Heart Rate, Fetal, Ultrasonic
- Device class
- Class 2
- Regulation
- 21 CFR 884.2660
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code HEL
FDA has cleared devices under product code HEL between 1978 and 2001, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2001
- 1998
- 1997
- 1995
- 1994
- 1978
Top applicants under product code HEL
Recent clearances under product code HEL
- K003876 — US SENSOR #CG-930P; TOCO SENSOR CG-940P
- K010920 — TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
- K982651 — COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
- K971240 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
- K930714 — SONICAID MODEL TEAM FECG IUP
- K933816 — SONICAID MODEL P110 FETAL HEAR DETECTOR
- K780035 — MINIVISOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.