Cypress Medical Products Stethoscope
FDA 510(k) K945082 · Cypress Medical Products, Ltd.
510(k) numberK945082
Submission
- Device name
- Cypress Medical Products Stethoscope
- Applicant
- Cypress Medical Products, Ltd.
Mc Henry, IL, US - Received
- October 17, 1994
- Decision date
- December 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K895545 | V*S*R(Tm) ScopeLDE · Traditional | Vsr Enterprises Corp. | 11/15/1989SE |
More from Vsr Enterprises Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K021676 | Cypress Medical Products, LP Disposable Vaginal Speculum, Non-MetalHIB · Traditional | 07/12/2002SE |
| K012282 | Sterile Powder Free Synthetic Vinyl Patient Exam GloveLYZ · Traditional | 08/06/2001SE |
| K972899 | Cypress Medical Products Aneroid SphygmomanometerDXQ · Traditional | 07/07/1998SE |
| K972849 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 05/28/1998SE |
| K972883 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 02/26/1998SE |
| K952367 | Cypress Medical Products Vinyl Examination GloveLYY · Traditional | 07/05/1995SE |
| K950254 | Cypress Medical Products Sterile Latex Examination GloveLYY · Traditional | 03/31/1995SE |
| K950109 | Cypress Medical Products Catheter (Insertion) Tray/With Out CatheterFCM · Traditional | 02/27/1995SESK |
| K950092 | Cypress Medical Products Catheter (Insertion) TrayFCM · Traditional | 02/27/1995SESK |
| K921988 | Laceration Repair TrayMDM · Traditional | 11/19/1992SEKD |
Questions and answers
When was Cypress Medical Products Stethoscope cleared by the FDA?
Cypress Medical Products Stethoscope (K945082) received a 510(k) decision of Substantially Equivalent on December 8, 1994, 52 days after the submission was received.
What is the product code of K945082?
The FDA product code is LDE – Stethoscope, Manual, a Class I (low risk) device regulated under 21 CFR 870.1875.