The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Cam-10 Battery Pack (#7-001).
Device ID | K791188 |
510k Number | K791188 |
Device Name: | CAM-10 BATTERY PACK (#7-001) |
Classification | Ventilator, Continuous, Facility Use |
Applicant | LIFECARE SERVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-26 |
Decision Date | 1979-07-05 |