The following data is part of a premarket notification filed by Pro-tech Services, Inc. with the FDA for Modification Ez-1 System Repiratory Sensors.
| Device ID | K013905 |
| 510k Number | K013905 |
| Device Name: | MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS |
| Classification | Ventilatory Effort Recorder |
| Applicant | PRO-TECH SERVICES, INC. 4338 HARBOUR POINTE BLVD. S.W. Mukilteo, WA 98275 |
| Contact | Neil Sheller |
| Correspondent | Neil Sheller PRO-TECH SERVICES, INC. 4338 HARBOUR POINTE BLVD. S.W. Mukilteo, WA 98275 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-26 |
| Decision Date | 2002-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959010741 | K013905 | 000 |
| 00606959010543 | K013905 | 000 |
| 00606959010512 | K013905 | 000 |
| 00606959010505 | K013905 | 000 |
| 00606959010499 | K013905 | 000 |
| 00606959010482 | K013905 | 000 |
| 00606959010437 | K013905 | 000 |
| 00606959010420 | K013905 | 000 |
| 00606959010413 | K013905 | 000 |
| 00606959010406 | K013905 | 000 |
| 00606959010390 | K013905 | 000 |
| 00606959010383 | K013905 | 000 |
| 00606959010376 | K013905 | 000 |
| 00606959010369 | K013905 | 000 |
| 00606959005112 | K013905 | 000 |
| 00606959005082 | K013905 | 000 |
| 00606959004818 | K013905 | 000 |
| 00606959010550 | K013905 | 000 |
| 00606959010567 | K013905 | 000 |
| 00606959010734 | K013905 | 000 |
| 00606959010727 | K013905 | 000 |
| 00606959010710 | K013905 | 000 |
| 00606959010703 | K013905 | 000 |
| 00606959010697 | K013905 | 000 |
| 00606959010680 | K013905 | 000 |
| 00606959010673 | K013905 | 000 |
| 00606959010666 | K013905 | 000 |
| 00606959010659 | K013905 | 000 |
| 00606959010642 | K013905 | 000 |
| 00606959010635 | K013905 | 000 |
| 00606959010628 | K013905 | 000 |
| 00606959010611 | K013905 | 000 |
| 00606959010598 | K013905 | 000 |
| 00606959010581 | K013905 | 000 |
| 00606959010574 | K013905 | 000 |
| 00606959004696 | K013905 | 000 |