Proscopes and Adscopes
FDA 510(k) K935944 · American Diagnostic Corp.
510(k) numberK935944
Submission
- Device name
- Proscopes and Adscopes
- Applicant
- American Diagnostic Corp.
West Babylon, NY, US - Received
- December 13, 1993
- Decision date
- March 3, 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K162589 | Adscope 658 Electronic StethoscopeDQD · Traditional | 03/10/2017SE |
| K093495 | Otoscope and Ophthalmoscope Diagnostic Instrument KitsHLJ · Traditional | 11/19/2010SE |
| K060321 | Adscope 657BK Electronic Stethoscope, Model 657BKDQD · Traditional | 05/15/2006SE |
| K012304 | Adc 656 Electronic StethoscopeDQD · Traditional | 11/01/2001SE |
| K962655 | Aneroid and Mercurial SphygmomanometersDXQ · Traditional | 01/27/1997SE |
| K940686 | Electronic ThermometersFLL · Traditional | 07/08/1994SE |
| K932145 | Coagulation Reference Plasma, NormalGIZ · Traditional | 10/18/1993SE |
| K894169 | Biotel Microalbuminuria (TM)JIR · Traditional | 09/18/1989SE |
| K893608 | Actichrome Atiii KitJBQ · Traditional | 06/23/1989SE |
| K884941 | Acticlot C KitGGP · Traditional | 03/13/1989SE |
Questions and answers
When was Proscopes and Adscopes cleared by the FDA?
Proscopes and Adscopes (K935944) received a 510(k) decision of Substantially Equivalent on March 3, 1994, 80 days after the submission was received.
What is the product code of K935944?
The FDA product code is LDE – Stethoscope, Manual, a Class I (low risk) device regulated under 21 CFR 870.1875.