The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Card Guard, Models Cg-6000 & Cg-7000.
| Device ID | K910884 |
| 510k Number | K910884 |
| Device Name: | CARD GUARD, MODELS CG-6000 & CG-7000 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan CARD GUARD SCIENTIFIC SURVIVAL, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 -1109 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-04 |
| Decision Date | 1991-10-16 |