Acu-Alert
FDA 510(k) K791399 · Acumed Instruments Corp.
510(k) numberK791399
Submission
- Device name
- Acu-Alert
- Applicant
- Acumed Instruments Corp.
Mchenry, IL, US - Received
- July 16, 1979
- Decision date
- October 11, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Acumed Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K863627 | Micro Surgical Drill System · Traditional | 10/02/1986SE |
| K853660 | Micro Surgical Drill System · Traditional | 09/24/1985SE |
| K853659 | Powered Irrigation for Micro Surgical Drill · Traditional | 09/24/1985SE |
| K853658 | Burs for Micro Surgical Drill SystemGFF · Traditional | 09/24/1985SE |
| K791891 | Acu-Med Red Miser Hemothorax Blood Coll.CAC · Traditional | 12/05/1979SE |
| K791400 | Gastric Lavage Kit-DisposableGBQ · Traditional | 08/16/1979SE |
| K790901 | I.V. Tubing OrganizerFPA · Traditional | 06/27/1979SE |
Questions and answers
When was Acu-Alert cleared by the FDA?
Acu-Alert (K791399) received a 510(k) decision of Substantially Equivalent on October 11, 1979, 87 days after the submission was received.