The following data is part of a premarket notification filed by Dymedix, Inc. with the FDA for Respiratory Belt Sensor, Model 6000s; Limb Movement Sensor, Model 3000s.
| Device ID | K001030 |
| 510k Number | K001030 |
| Device Name: | RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S |
| Classification | Monitor, Breathing Frequency |
| Applicant | DYMEDIX, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring DYMEDIX, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-30 |
| Decision Date | 2000-05-11 |