The following data is part of a premarket notification filed by Todd Industries, Inc. with the FDA for Lifeline Ippb Set-up.
Device ID | K810341 |
510k Number | K810341 |
Device Name: | LIFELINE IPPB SET-UP |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
Applicant | TODD INDUSTRIES, 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 | 1981-02-10 |
Decision Date | 1981-03-17 |