Various Types of: Keeler Magnatone 2 Stethoscopes:
FDA 510(k) K871369 · Keeler Instruments, Inc.
510(k) numberK871369
Submission
- Device name
- Various Types of: Keeler Magnatone 2 Stethoscopes:
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- April 7, 1987
- Decision date
- September 24, 1987
- 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 |
More from Kimball Industries Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | 12/08/2011SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
Questions and answers
When was Various Types of: Keeler Magnatone 2 Stethoscopes: cleared by the FDA?
Various Types of: Keeler Magnatone 2 Stethoscopes: (K871369) received a 510(k) decision of Substantially Equivalent on September 24, 1987, 170 days after the submission was received.
What is the product code of K871369?
The FDA product code is LDE – Stethoscope, Manual, a Class I (low risk) device regulated under 21 CFR 870.1875.