The following data is part of a premarket notification filed by Caditec Ag with the FDA for Cadiscope Electronic Stethoscope.
Device ID | K990809 |
510k Number | K990809 |
Device Name: | CADISCOPE ELECTRONIC STETHOSCOPE |
Classification | Stethoscope, Electronic |
Applicant | CADITEC AG ONE MEDICAL PLACE Mundelein, IL 60060 |
Contact | Betty Lock |
Correspondent | Betty Lock CADITEC AG ONE MEDICAL PLACE Mundelein, IL 60060 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-11 |
Decision Date | 1999-06-09 |
Summary: | summary |