510(k) K103634
K103634 is an FDA 510(k) premarket notification submitted by Ascom (Us), Inc. for the device "ASCOM CLINICALCONNEX CARDIOMAX". The FDA issued a decision of Substantially Equivalent on February 23, 2011. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2011
- Date Received
- December 13, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type