The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Body Position Indicator, Model Bpi1.
| Device ID | K940013 |
| 510k Number | K940013 |
| Device Name: | BODY POSITION INDICATOR, MODEL BPI1 |
| Classification | Ventilatory Effort Recorder |
| Applicant | PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville, WA 98072 |
| Contact | Randy Carruthers |
| Correspondent | Randy Carruthers PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville, WA 98072 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-04 |
| Decision Date | 1995-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959011182 | K940013 | 000 |
| 00606959011175 | K940013 | 000 |
| 00606959011168 | K940013 | 000 |
| 00606959011120 | K940013 | 000 |
| 00606959011113 | K940013 | 000 |
| 00606959004801 | K940013 | 000 |
| 00606959029163 | K940013 | 000 |
| 00606959027107 | K940013 | 000 |