Palpation Enhancer
FDA 510(k) K801811 · Medical Horizons Co.
510(k) numberK801811
Submission
- Device name
- Palpation Enhancer
- Applicant
- Medical Horizons Co.
Mchenry, IL, US - Received
- July 8, 1980
- Decision date
- September 9, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDE – Stethoscope, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.1875
- Specialty
- Cardiovascular
Other 510(k)s with product code LDE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945082 | Cypress Medical Products StethoscopeLDE · Traditional | Cypress Medical Products, Ltd. | 12/08/1994SE |
| K944337 | Various StethoscopesLDE · Traditional | Rud Riester GmbH & CO KG | 11/30/1994SE |
| K940578 | Manual StetoscopeLDE · Traditional | Bhs Intl., Inc. | 04/26/1994SE |
| K935944 | Proscopes and AdscopesLDE · Traditional | American Diagnostic Corp. | 03/03/1994SE |
| K923327 | Stethoscope CoverLDE · Traditional | Anup Chakraborty Co. | 11/03/1992SE |
| K924095 | Timeoscope and FlexiscopeLDE · Traditional | Stethoscopes of America, Inc. | 10/20/1992SE |
| K914100 | StethoscopeLDE · Traditional | Atlas Medical Products, Inc. | 11/07/1991SE |
| K912128 | Maxi-Scope or Ultra-ScopeLDE · Traditional | Seiichi Mfg., Inc. | 06/28/1991SE |
| K905487 | Various Types of StethoscopesLDE · Traditional | Liaoning-Usa Corp. | 04/09/1991SE |
| K904547 | StethoscopeLDE · Traditional | Kimball Industries Co., Ltd. | 03/21/1991SE |
Questions and answers
When was Palpation Enhancer cleared by the FDA?
Palpation Enhancer (K801811) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 63 days after the submission was received.
What is the product code of K801811?
The FDA product code is LDE – Stethoscope, Manual, a Class I (low risk) device regulated under 21 CFR 870.1875.