510(k) K093925
K093925 is an FDA 510(k) premarket notification submitted by Physio-Control, Inc. for the device "LIFENET SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 2010. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Physio-Control, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2010
- Date Received
- December 22, 2009
- Clearance Type
- Special
- 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