Submission Details
| 510(k) Number | K093925 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2009 |
| Decision Date | January 12, 2010 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
LIFENET SYSTEM
Jan 2010
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K093925 is an FDA 510(k) clearance for the LIFENET SYSTEM, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on January 12, 2010, 21 days after receiving the submission on December 22, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.
Device Classification
| Product Code | MSX — System, Network And Communication, Physiological Monitors |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
Manufacturer
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