The following data is part of a premarket notification filed by Biomec, Inc. with the FDA for Sleepflo, Model 101501.
| Device ID | K020607 |
| 510k Number | K020607 |
| Device Name: | SLEEPFLO, MODEL 101501 |
| Classification | Ventilatory Effort Recorder |
| Applicant | BIOMEC, INC. 1771 EAST 30TH ST. Cleveland, OH 44114 -4407 |
| Contact | Tracey H Wielinski |
| Correspondent | Tracey H Wielinski BIOMEC, INC. 1771 EAST 30TH ST. Cleveland, OH 44114 -4407 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-25 |
| Decision Date | 2002-08-30 |
| Summary: | summary |