The following data is part of a premarket notification filed by Erich Jaeger Gmbh with the FDA for Ms Paed-baby Body.
Device ID | K023796 |
510k Number | K023796 |
Device Name: | MS PAED-BABY BODY |
Classification | Plethysmograph, Pressure |
Applicant | ERICH JAEGER GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
Contact | Earl Draper |
Correspondent | Earl Draper ERICH JAEGER GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
Product Code | CCM |
CFR Regulation Number | 868.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-13 |
Decision Date | 2003-03-03 |
Summary: | summary |