The following data is part of a premarket notification filed by Life Sensing Instrument Company, Inc. with the FDA for Hts 820 Cardiac Monitor.
| Device ID | K896967 |
| 510k Number | K896967 |
| Device Name: | HTS 820 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 | 1989-12-18 |
| Decision Date | 1990-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864037000392 | K896967 | 000 |
| 00857769008057 | K896967 | 000 |
| 00857769008064 | K896967 | 000 |
| 00857769008071 | K896967 | 000 |
| 00857769008040 | K896967 | 000 |
| 00857769008033 | K896967 | 000 |
| 00857769008026 | K896967 | 000 |
| 00857769008019 | K896967 | 000 |
| 00857769008002 | K896967 | 000 |
| 00864037000309 | K896967 | 000 |
| 00864037000316 | K896967 | 000 |
| 00864037000323 | K896967 | 000 |
| 00864037000330 | K896967 | 000 |
| 00864037000354 | K896967 | 000 |
| 00864037000378 | K896967 | 000 |
| 00864037000385 | K896967 | 000 |
| 00857769008088 | K896967 | 000 |