The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Cam-10 Respiratory Hose Assemblies.
Device ID | K801859 |
510k Number | K801859 |
Device Name: | CAM-10 RESPIRATORY HOSE ASSEMBLIES |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
Applicant | LIFECARE SERVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZO |
CFR Regulation Number | 868.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-05 |
Decision Date | 1980-09-09 |