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 |