510(k) K011824
K011824 is an FDA 510(k) premarket notification submitted by Agilent Technologies, Inc. for the device "AGILENT M2636B TELEMON B MONITOR (TELEMON B)". The FDA issued a decision of Substantially Equivalent on July 2, 2001. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Agilent Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2001
- Date Received
- June 11, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type