The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Alveo-diffusion Test.
| Device ID | K853443 |
| 510k Number | K853443 |
| Device Name: | ALVEO-DIFFUSION TEST |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | ERICH JAEGER, INC. 5251 ZENITH PKWY. Rockford, IL 61111 |
| Contact | Ronald Evenson |
| Correspondent | Ronald Evenson ERICH JAEGER, INC. 5251 ZENITH PKWY. Rockford, IL 61111 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-16 |
| Decision Date | 1986-02-21 |