Imv System
FDA 510(k) K780340 · Lkb Instruments, Inc.
510(k) numberK780340
Submission
- Device name
- Imv System
- Applicant
- Lkb Instruments, Inc.
- Received
- March 1, 1978
- Decision date
- November 27, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBD – Bottle, Collection, Breathing System (Calibrated)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code CBD
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Questions and answers
When was Imv System cleared by the FDA?
Imv System (K780340) received a 510(k) decision of Substantially Equivalent on November 27, 1978, 271 days after the submission was received.
What is the product code of K780340?
The FDA product code is CBD – Bottle, Collection, Breathing System (Calibrated), a Class II (moderate risk) device regulated under 21 CFR 880.6740.