The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Master Screen Pnuemo.
Device ID | K933839 |
510k Number | K933839 |
Device Name: | MASTER SCREEN PNUEMO |
Classification | Calculator, Predicted Values, Pulmonary Function |
Applicant | ERICH JAEGER, INC. P.O. BOX 10008 Rockford, IL 61131 |
Contact | A.g. Keim |
Correspondent | A.g. Keim ERICH JAEGER, INC. P.O. BOX 10008 Rockford, IL 61131 |
Product Code | BTY |
CFR Regulation Number | 868.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-05 |
Decision Date | 1994-03-07 |