The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Lifenet System.
Device ID | K102757 |
510k Number | K102757 |
Device Name: | LIFENET SYSTEM |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | PHYSIO-CONTROL, INC. 11811 WILLOWS ROAD NORTHEAST P.O. BOX 97006 Redmond, WA 98073 -9706 |
Contact | Teresa Davidson |
Correspondent | Teresa Davidson PHYSIO-CONTROL, INC. 11811 WILLOWS ROAD NORTHEAST P.O. BOX 97006 Redmond, WA 98073 -9706 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-23 |
Decision Date | 2010-11-05 |
Summary: | summary |