Clearance Summary
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural received FDA 510(k) clearance under submission number K150903, sponsored by Maanshan Bond Medical Instruments Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2015-07-15.
- Submission: K150903
- Applicant / Sponsor: Maanshan Bond Medical Instruments Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 2015-07-15
Classification & Regulation
This clearance is catalogued under FDA product code MQX and 21 CFR 880.5580, within the General Hospital review panel as a Class II device.