Patient Ventilator Isolator
FDA 510(k) K880923 · Dryden Corp.
510(k) numberK880923
Submission
- Device name
- Patient Ventilator Isolator
- Applicant
- Dryden Corp.
Indianapolis, IN, US - Received
- March 4, 1988
- Decision date
- September 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
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| K880769 | Breathing Circuit W/Heated WireBZE · Traditional | 08/24/1988SE |
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| K873928 | Universal TourniquetGAX · Traditional | 10/23/1987SE |
| K873927 | Reuseable Breathing TubesBZO · Traditional | 10/20/1987SE |
| K870859 | Bag-Tail Bleed ValveCAI · Traditional | 08/03/1987SE |
| K871386 | Breathing CircuitCAI · Traditional | 05/29/1987SE |
| K870858 | Badgwell Sampling CatheterCCK · Traditional | 05/14/1987SE |
| K861540 | Disposable Berman and Guedel AirwaysCAE · Traditional | 05/02/1986SE |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | 03/21/1985SE |
| K842843 | Dryden Scavenger Interface System · Traditional | 07/27/1984SE |
Questions and answers
When was Patient Ventilator Isolator cleared by the FDA?
Patient Ventilator Isolator (K880923) received a 510(k) decision of Substantially Equivalent on September 6, 1988, 186 days after the submission was received.
What is the product code of K880923?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.