The following data is part of a premarket notification filed by Medteq Innovations Pty Ltd with the FDA for Cpr Ezy Mask And Pad.
| Device ID | K003937 |
| 510k Number | K003937 |
| Device Name: | CPR EZY MASK AND PAD |
| Classification | Aid, Cardiopulmonary Resuscitation |
| Applicant | MEDTEQ INNOVATIONS PTY LTD 7361 CALHOUN PLACE, SUITE 500 Rockville, MD 20855 -2765 |
| Contact | Eduardo March |
| Correspondent | Eduardo March MEDTEQ INNOVATIONS PTY LTD 7361 CALHOUN PLACE, SUITE 500 Rockville, MD 20855 -2765 |
| Product Code | LIX |
| CFR Regulation Number | 870.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-20 |
| Decision Date | 2001-06-06 |