510(k) K110429
K110429 is an FDA 510(k) premarket notification submitted by Fluke Biomedical for the device "PROSIM 4, PROSIM 6, PROSIM 8". The FDA issued a decision of Substantially Equivalent on September 2, 2011. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Fluke Biomedical has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2011
- Date Received
- February 15, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type