The following data is part of a premarket notification filed by Life Sensing Instrument Company, Inc. with the FDA for Paragon 420, Cardiac Monitor.
| Device ID | K861067 |
| 510k Number | K861067 |
| Device Name: | PARAGON 420, CARDIAC MONITOR |
| Classification | Electrocardiograph |
| Applicant | LIFE SENSING INSTRUMENT COMPANY, INC. 329 W. LINCOLN ST. Tullahoma, TN 37388 |
| Contact | B. Q Cutshaw |
| Correspondent | B. Q Cutshaw LIFE SENSING INSTRUMENT COMPANY, INC. 329 W. LINCOLN ST. Tullahoma, TN 37388 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-20 |
| Decision Date | 1986-06-05 |