The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for King Of Hearts Express + Af Monitor.
| Device ID | K020825 |
| 510k Number | K020825 |
| Device Name: | KING OF HEARTS EXPRESS + AF MONITOR |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 6779 MESA RIDGE RD. SUITE 200 San Diego, CA 92121 -2909 |
| Contact | Alden Kay |
| Correspondent | Alden Kay CARD GUARD SCIENTIFIC SURVIVAL, LTD. 6779 MESA RIDGE RD. SUITE 200 San Diego, CA 92121 -2909 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-14 |
| Decision Date | 2002-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850725007088 | K020825 | 000 |