The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Pmp4 Oxy Pro.
| Device ID | K043162 |
| 510k Number | K043162 |
| Device Name: | PMP4 OXY PRO |
| Classification | Oximeter |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. PO BOX 527 Rehovot, IL 76100 |
| Contact | Boris Aradovsky |
| Correspondent | Boris Aradovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. PO BOX 527 Rehovot, IL 76100 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-16 |
| Decision Date | 2004-12-29 |
| Summary: | summary |