Anesthesia Breathing Circuits
FDA 510(k) K830470 · Mon-A-Therm, Inc.
510(k) numberK830470
Submission
- Device name
- Anesthesia Breathing Circuits
- Applicant
- Mon-A-Therm, Inc.
Mchenry, IL, US - Received
- February 15, 1983
- Decision date
- March 24, 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
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 |
|---|---|---|
| K885187 | Model 1000 Electronic Clinical ThermometerFLL · Traditional | 03/08/1989SE |
| K874522 | Modified Myocardial Temperature SensorKRB · Traditional | 01/29/1988SE |
| K874519 | Modified Esophageal Stethoscope/Temperature SensorBZW · Traditional | 01/29/1988SE |
| K875234 | Mon-A-Therm's Skin Temperature SensorFLL · Traditional | 01/19/1988SE |
| K874525 | Modified Foley Catheter/Temperature SensorKOD · Traditional | 01/06/1988SE |
| K874524 | Modified Subcutaneous Temperature SensorFLL · Traditional | 01/06/1988SE |
| K874523 | Modified Tympanic & Esophageal/Rectal Temp. SensorFLL · Traditional | 01/06/1988SE |
| K874521 | Modified Thermal Well Temperature SensorFLL · Traditional | 01/06/1988SE |
| K874520 | Modified Airway Temperature SensorFLL · Traditional | 01/06/1988SE |
| K853392 | Mon-A-Therm Subcutaneous Temp. SensorFLL · Traditional | 11/22/1985SE |
Questions and answers
When was Anesthesia Breathing Circuits cleared by the FDA?
Anesthesia Breathing Circuits (K830470) received a 510(k) decision of Substantially Equivalent on March 24, 1983, 37 days after the submission was received.
What is the product code of K830470?
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.