Littman Type SH-6010, Nurse Type
FDA 510(k) K842203 · Cher Mel Corp.
510(k) numberK842203
Submission
- Device name
- Littman Type SH-6010, Nurse Type
- Applicant
- Cher Mel Corp.
Mchenry, IL, US - Received
- June 4, 1984
- Decision date
- June 6, 1985
- 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 |
|---|---|---|
| K863040 | Disposable Intravenous Hyperalimentation BagsKPE · Traditional | 10/31/1986SE |
| K851516 | Chermel Scalp Vein SetFPA · Traditional | 08/23/1985SE |
| K843324 | Sprague RAPPAPORT/SH-6008 Dispos. StethLDE · Traditional | 06/06/1985SE |
| K842824 | Chermel Bone ChiselsKDG · Traditional | 08/02/1984SE |
| K842823 | Chermel OsteotomesGFI · Traditional | 08/02/1984SE |
| K842822 | Chermel Bone GougesGDH · Traditional | 08/02/1984SE |
Questions and answers
When was Littman Type SH-6010, Nurse Type cleared by the FDA?
Littman Type SH-6010, Nurse Type (K842203) received a 510(k) decision of Substantially Equivalent on June 6, 1985, 367 days after the submission was received.
What is the product code of K842203?
The FDA product code is LDE – Stethoscope, Manual, a Class I (low risk) device regulated under 21 CFR 870.1875.