The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Bennett Volume Ventilator Circuit.
Device ID | K812773 |
510k Number | K812773 |
Device Name: | BENNETT VOLUME VENTILATOR CIRCUIT |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
Applicant | IDEAL MEDICAL, 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 | 1981-10-05 |
Decision Date | 1981-10-23 |