Quicktest System
FDA 510(k) K920015 · Q.I. Medical, Inc.
510(k) numberK920015
Submission
- Device name
- Quicktest System
- Applicant
- Q.I. Medical, Inc.
Nevada City, CA, US - Received
- January 2, 1992
- Decision date
- November 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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More from Sfm Medical Devices GmbH
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| K950305 | Qtmicro(Tm) SystemLHI · Traditional | 10/13/1995SE |
Questions and answers
When was Quicktest System cleared by the FDA?
Quicktest System (K920015) received a 510(k) decision of Substantially Equivalent on November 23, 1992, 326 days after the submission was received.
What is the product code of K920015?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.