The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Tm2000 Fetaltrace Transtelephonic Receiving Center.
| Device ID | K021574 |
| 510k Number | K021574 |
| Device Name: | TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER |
| Classification | System, Monitoring, Perinatal |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. PO BOX 527 Rehovot, IL 76100 |
| Contact | Alex Gonorovsky |
| Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. PO BOX 527 Rehovot, IL 76100 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-14 |
| Decision Date | 2002-08-12 |
| Summary: | summary |