510(k) K855102
K855102 is an FDA 510(k) premarket notification submitted by Equilibrated Bio Systems, Inc. for the device "MONARK 869 ERGOMETER". The FDA issued a decision of Substantially Equivalent on May 9, 1986. The device falls under product code DSP (System, Balloon, Intra-Aortic And Control), a Class II device regulated under 21 CFR 870.3535. Equilibrated Bio Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1986
- Date Received
- December 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Balloon, Intra-Aortic And Control
- Device Class
- Class II
- Regulation Number
- 870.3535
- Review Panel
- CV
- Submission Type