510(k) K113835
K113835 is an FDA 510(k) premarket notification submitted by Capsule Tech, Inc. for the device "DATACAPTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on June 27, 2012. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2012
- Date Received
- December 27, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type