The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Microtrapper/microdigitrapper, Add Modifications.
Device ID | K924875 |
510k Number | K924875 |
Device Name: | MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS |
Classification | Monitor, Breathing Frequency |
Applicant | SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
Contact | Anna Pettersson |
Correspondent | Anna Pettersson SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-14 |
Decision Date | 1994-06-30 |