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 |