Maxi-Scope or Ultra-Scope
FDA 510(k) K912128 · Seiichi Mfg., Inc.
510(k) numberK912128
Submission
- Device name
- Maxi-Scope or Ultra-Scope
- Applicant
- Seiichi Mfg., Inc.
Jamestown, KY, US - Received
- May 14, 1991
- Decision date
- June 28, 1991
- 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 |
| 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 |
| 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 |
Questions and answers
When was Maxi-Scope or Ultra-Scope cleared by the FDA?
Maxi-Scope or Ultra-Scope (K912128) received a 510(k) decision of Substantially Equivalent on June 28, 1991, 45 days after the submission was received.
What is the product code of K912128?
The FDA product code is LDE – Stethoscope, Manual, a Class I (low risk) device regulated under 21 CFR 870.1875.