510(k) K110957
K110957 is an FDA 510(k) premarket notification submitted by Spectrum Medical, Llp for the device "M4 MONITOR". The FDA issued a decision of Substantially Equivalent on May 31, 2011. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. Spectrum Medical, Llp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2011
- Date Received
- April 5, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4330
- Review Panel
- CV
- Submission Type