The following data is part of a premarket notification filed by Erich Jaeger Gmbh & Co. Kg with the FDA for Masterscreen Body.
| Device ID | K936108 |
| 510k Number | K936108 |
| Device Name: | MASTERSCREEN BODY |
| Classification | Plethysmograph, Volume |
| Applicant | ERICH JAEGER GMBH & CO. KG POSTFACH 5846, 8700 WUERZBURG 1 Wuerzburg, Germany, DE |
| Contact | V.d. Grother |
| Correspondent | V.d. Grother ERICH JAEGER GMBH & CO. KG POSTFACH 5846, 8700 WUERZBURG 1 Wuerzburg, Germany, DE |
| Product Code | JEH |
| CFR Regulation Number | 868.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1995-02-03 |