The following data is part of a premarket notification filed by Erich Jaeger Gmbh & Co. Kg with the FDA for Masterscreen Ios.
| Device ID | K954140 |
| 510k Number | K954140 |
| Device Name: | MASTERSCREEN IOS |
| Classification | Spirometer, Diagnostic |
| Applicant | ERICH JAEGER GMBH & CO. KG HOCHBERG D-97204 POSTFACH/P.O. BOX 5846 Wurzburg D-97008, DE |
| Contact | Detlef Grotheer |
| Correspondent | Detlef Grotheer ERICH JAEGER GMBH & CO. KG HOCHBERG D-97204 POSTFACH/P.O. BOX 5846 Wurzburg D-97008, DE |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-01 |
| Decision Date | 1995-12-14 |