The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Oxyscreen.
Device ID | K843860 |
510k Number | K843860 |
Device Name: | OXYSCREEN |
Classification | Calculator, Pulmonary Function Data |
Applicant | ERICH JAEGER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZC |
CFR Regulation Number | 868.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-01 |
Decision Date | 1984-12-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OXYSCREEN 76491849 not registered Dead/Abandoned |
ABCO Laboratories, Inc. 2003-02-21 |