The following data is part of a premarket notification filed by Zee Medical Products Co., Inc. with the FDA for Zee Manual Resuscitator.
Device ID | K812022 |
510k Number | K812022 |
Device Name: | ZEE MANUAL RESUSCITATOR |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | ZEE MEDICAL PRODUCTS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-20 |
Decision Date | 1981-07-31 |