510(k) K110374
K110374 is an FDA 510(k) premarket notification submitted by Medicore Co., Ltd. for the device "MAX PULSE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 2011. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Medicore Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2011
- Date Received
- February 9, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device Class
- Class II
- Regulation Number
- 870.2780
- Review Panel
- CV
- Submission Type