The following data is part of a premarket notification filed by Medical Services Of America, Inc. with the FDA for Aircare Oxygen Generator.
Device ID | K790520 |
510k Number | K790520 |
Device Name: | AIRCARE OXYGEN GENERATOR |
Classification | Generator, Oxygen, Portable |
Applicant | MEDICAL SERVICES OF AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-16 |
Decision Date | 1979-04-18 |