The following data is part of a premarket notification filed by Cardionics, Inc. with the FDA for Spectrum Polycord I Recorder System.
| Device ID | K862776 |
| 510k Number | K862776 |
| Device Name: | SPECTRUM POLYCORD I RECORDER SYSTEM |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | CARDIONICS, INC. 1100 HERCULES, SUITE 210 Houston, TX 77058 |
| Contact | Keith H Johnson |
| Correspondent | Keith H Johnson CARDIONICS, INC. 1100 HERCULES, SUITE 210 Houston, TX 77058 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-22 |
| Decision Date | 1986-08-18 |