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 Cardiac Event Recorder.
| Device ID | K111745 |
| 510k Number | K111745 |
| Device Name: | KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo CARD GUARD SCIENTIFIC SURVIVAL, LTD. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-21 |
| Decision Date | 2011-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850725007071 | K111745 | 000 |