The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Microtrapper/microdigitrapper, Modification.
Device ID | K905520 |
510k Number | K905520 |
Device Name: | MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION |
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 | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-07 |
Decision Date | 1991-04-26 |