The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard Model Cg-900.
| Device ID | K960553 |
| 510k Number | K960553 |
| Device Name: | CARD GUARD MODEL CG-900 |
| Classification | System, Monitoring, Perinatal |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 3649 SEHORN DR. Malibu, CA 90265 |
| Contact | Anne Lauritzen |
| Correspondent | Anne Lauritzen CARD GUARD SCIENTIFIC SURVIVAL, LTD. 3649 SEHORN DR. Malibu, CA 90265 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-08 |
| Decision Date | 1997-04-22 |