The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Hl 200 Electronic Stethoscope.
| Device ID | K050169 |
| 510k Number | K050169 |
| Device Name: | HL 200 ELECTRONIC STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | HEALTH & LIFE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich HEALTH & LIFE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-26 |
| Decision Date | 2005-04-05 |
| Summary: | summary |