HL 200 Electronic Stethoscope
FDA 510(k) K050169 · Health & Life Co., Ltd.
510(k) numberK050169
Submission
- Device name
- HL 200 Electronic Stethoscope
- Applicant
- Health & Life Co., Ltd.
Flagstaff, AZ, US - Received
- January 26, 2005
- Decision date
- April 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQD – Stethoscope, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1875
- Specialty
- Cardiovascular
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| K180240 | Full Automatic(NIBP) Blood Pressure MonitorDXN · Traditional | 10/17/2018SE |
| K162338 | Full Automatic (NIBP) Blood Pressure MonitorDXN · Special | 09/21/2016SE |
| K160557 | Full Automatic (NIBP) Blood Pressure MonitorDXN · Traditional | 07/06/2016SE |
| K161156 | Full Automatic (NIBP) Blood Pressure MonitorDXN · Traditional | 06/14/2016SE |
Questions and answers
When was HL 200 Electronic Stethoscope cleared by the FDA?
HL 200 Electronic Stethoscope (K050169) received a 510(k) decision of Substantially Equivalent on April 5, 2005, 69 days after the submission was received.
What is the product code of K050169?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.