Submission Details
| 510(k) Number | K102757 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 2010 |
| Decision Date | November 05, 2010 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
LIFENET SYSTEM
Nov 2010
Decision
43d
Days
Class 2
Risk
About This 510(k) Submission
K102757 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 November 5, 2010, 43 days after receiving the submission on September 23, 2010. 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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