The following data is part of a premarket notification filed by Artec Environmental Monitoring Division with the FDA for Mouth To Face Resuscitator.
| Device ID | K873043 |
| 510k Number | K873043 |
| Device Name: | MOUTH TO FACE RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | ARTEC ENVIRONMENTAL MONITORING DIVISION P.O. BOX 68 Noblesville, IN 46060 |
| Contact | Timothy D Struthers |
| Correspondent | Timothy D Struthers ARTEC ENVIRONMENTAL MONITORING DIVISION P.O. BOX 68 Noblesville, IN 46060 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-04 |
| Decision Date | 1987-09-28 |