Slimb Single Limb Breathing Circuit
FDA 510(k) K832453 · Respiratory Care, Inc.
510(k) numberK832453
Submission
- Device name
- Slimb Single Limb Breathing Circuit
- Applicant
- Respiratory Care, Inc.
Mchenry, IL, US - Received
- July 26, 1983
- Decision date
- October 27, 1983
- 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
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| 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 |
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| K892230 | Rci Viral/Bacterial FilterCAH · Traditional | 08/28/1989SE |
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| K881625 | Conchatherm III Plus Dual Heat Wire Servo ControllBZE · Traditional | 06/21/1988SE |
| K864147 | AquavalveBYH · Traditional | 12/05/1986SE |
| K863955 | Colby Level AlarmBTT · Traditional | 11/07/1986SE |
| K861555 | Circapak Universal Volume Ventilator CircuitBZD · Traditional | 06/05/1986SE |
| K834151 | Conchatherm LHF Humidifier HeaterBTT · Traditional | 01/13/1984SE |
| K833974 | Aquapak 020 Humidifier AdapterBTT · Traditional | 12/16/1983SE |
| K811524 | AquacadeLHC · Traditional | 07/01/1981SE |
| K811073 | A QuapakBTT · Traditional | 04/29/1981SE |
Questions and answers
When was Slimb Single Limb Breathing Circuit cleared by the FDA?
Slimb Single Limb Breathing Circuit (K832453) received a 510(k) decision of Substantially Equivalent on October 27, 1983, 93 days after the submission was received.
What is the product code of K832453?
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.