Conductive Anesthesia Breathing Circuit
FDA 510(k) K760819 · Omnicon Medical Corp.
510(k) numberK760819
Submission
- Device name
- Conductive Anesthesia Breathing Circuit
- Applicant
- Omnicon Medical Corp.
Mchenry, IL, US - Received
- October 12, 1976
- Decision date
- October 27, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAI – Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5240
- Specialty
- Anesthesiology
Other 510(k)s with product code CAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954480 | Condensate Collection KitCAI · Traditional | Nova-Ventrx | 12/29/1995SE |
| K953788 | Unicor, Inc. Gas Sampling Lines & ConnectorsCAI · Traditional | Unicor, Inc. | 09/19/1995SE |
| K953787 | Unicor, Inc. Adult Anesthesia Breathing CircuitCAI · Traditional | Unicor, Inc. | 09/19/1995SE |
| K952020 | Prima Pediatric Anesthesia CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952019 | Prima Adult Gas Sampling CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952018 | Prima Coaxial CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952017 | Prima Mapleson D CircuitCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952016 | Prima Pediatric Gas Sampling CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952014 | Prima Adult Temperature Monitoring Anesthesia CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952009 | Prima Pediatric Temperature Monitoring CircuitsCAI · Traditional | Prima, Inc. | 05/19/1995SE |
More from Prima, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K823872 | Emergency Tracheostomy KitEWC · Traditional | 01/21/1983SE |
| K820577 | Anesthesia Bacteria FilterCAH · Traditional | 03/18/1982SE |
| K820576 | Mainflow Bacteria FilterCAH · Traditional | 03/18/1982SE |
| K801804 | Anesthesia Bacteria FilterCAH · Traditional | 08/13/1980SE |
| K801803 | Mainflow Bacteria FilterCAH · Traditional | 08/13/1980SE |
| K772060 | Protect IV GardFMP · Traditional | 12/20/1977SE |
| K770136 | Disposable Bacteria FilterCAH · Traditional | 02/14/1977SE |
| K770001 | Airway, Berman 40, 60, 80, 90, L00MM'SCAE · Traditional | 01/12/1977SE |
| K760149 | Conductive Anesthsia Breath. CircuitCAI · Traditional | 07/19/1976SE |
Questions and answers
When was Conductive Anesthesia Breathing Circuit cleared by the FDA?
Conductive Anesthesia Breathing Circuit (K760819) received a 510(k) decision of Substantially Equivalent on October 27, 1976, 15 days after the submission was received.
What is the product code of K760819?
The FDA product code is CAI – Circuit, Breathing (W Connector, Adaptor, Y Piece), a Class I (low risk) device regulated under 21 CFR 868.5240.