Unicor, Inc. Adult Anesthesia Breathing Circuit
FDA 510(k) K953787 · Unicor, Inc.
510(k) numberK953787
Submission
- Device name
- Unicor, Inc. Adult Anesthesia Breathing Circuit
- Applicant
- Unicor, Inc.
Cleveland, TN, US - Received
- August 14, 1995
- Decision date
- September 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K945565 | Spiro-FlexCAI · Traditional | Inhalation Plastics | 01/13/1995SE |
More from Inhalation Plastics
| 510(k) | Device | Decision |
|---|---|---|
| K953788 | Unicor, Inc. Gas Sampling Lines & ConnectorsCAI · Traditional | 09/19/1995SE |
| K953786 | Unicor, Inc. Connectors & Airway ExtensionsBZA · Traditional | 09/19/1995SE |
| K953784 | Unicor, Inc. Corrugated TubingBZO · Traditional | 09/19/1995SE |
| K953785 | Unicor, Inc. Ventilator HosesBZO · Traditional | 09/18/1995SE |
Questions and answers
When was Unicor, Inc. Adult Anesthesia Breathing Circuit cleared by the FDA?
Unicor, Inc. Adult Anesthesia Breathing Circuit (K953787) received a 510(k) decision of Substantially Equivalent on September 19, 1995, 36 days after the submission was received.
What is the product code of K953787?
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.