Be 410 Endotracheal Tube/Trach Tube, Pilot Repair
FDA 510(k) K884638 · Instrumentation Industries, Inc.
510(k) numberK884638
Submission
- Device name
- Be 410 Endotracheal Tube/Trach Tube, Pilot Repair
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- November 7, 1988
- Decision date
- November 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSK – Cuff, Tracheal Tube, Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5750
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Be 410 Endotracheal Tube/Trach Tube, Pilot Repair cleared by the FDA?
Be 410 Endotracheal Tube/Trach Tube, Pilot Repair (K884638) received a 510(k) decision of Substantially Equivalent on November 23, 1988, 16 days after the submission was received.
What is the product code of K884638?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.