The following data is part of a premarket notification filed by Artec Environmental Monitoring Division with the FDA for Artec Respond Pulmonary Resuscitator.
| Device ID | K896886 |
| 510k Number | K896886 |
| Device Name: | ARTEC RESPOND PULMONARY RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | ARTEC ENVIRONMENTAL MONITORING DIVISION 8804 BASH ST. SUITE A, P.O. BOX 50627 Indianapolis, IN 46256 |
| Contact | E Notarianni |
| Correspondent | E Notarianni ARTEC ENVIRONMENTAL MONITORING DIVISION 8804 BASH ST. SUITE A, P.O. BOX 50627 Indianapolis, IN 46256 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-08 |
| Decision Date | 1990-02-06 |