The following data is part of a premarket notification filed by Life Sensing Instrument Company, Inc. with the FDA for Hts 220 Cardiac Monitor.
| Device ID | K884524 |
| 510k Number | K884524 |
| Device Name: | HTS 220 CARDIAC MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-27 |
| Decision Date | 1989-04-10 |