Ambu Ruben Circle Anesthesia System
FDA 510(k) K844149 · Ambu, Inc.
510(k) numberK844149
Submission
- Device name
- Ambu Ruben Circle Anesthesia System
- Applicant
- Ambu, Inc.
Danbury, CT, US - Received
- October 24, 1984
- Decision date
- November 15, 1984
- 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 |
|---|---|---|
| K051529 | Ambu Neuroline GroundGXY · Traditional | 08/04/2005SE |
| K042682 | Ambu Spur Ii. Adult Single Patient ResuscitatorBTM · Traditional | 11/15/2004SE |
| K042843 | Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsBTM · Traditional | 11/12/2004SE |
| K041734 | Ambu Disposable ECG ElectrodeDRX · Traditional | 09/22/2004SE |
| K040991 | Ambu Disposable Pressure ManometerCAP · Traditional | 07/22/2004SE |
| K041026 | Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-SDRX · Traditional | 06/28/2004SE |
| K032278 | Ambu Neuroline Single Patient Eeg/Ep Cup ElectrodeGXY · Traditional | 03/05/2004SE |
| K032421 | Ambu Pediatric Multi-Function Defibrillation ElectrodeMKJ · Traditional | 02/27/2004SE |
| K010583 | Ambu Gel, Hydrogel Burn DressingMGQ · Traditional | 05/25/2001SE |
| K993278 | Ambu Neonate Silicone ResuscitatorBTM · Traditional | 05/17/2000SE |
Questions and answers
When was Ambu Ruben Circle Anesthesia System cleared by the FDA?
Ambu Ruben Circle Anesthesia System (K844149) received a 510(k) decision of Substantially Equivalent on November 15, 1984, 22 days after the submission was received.
What is the product code of K844149?
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.