Pediatric Intubation Circuit
FDA 510(k) K840056 · Ackrad Laboratories
510(k) numberK840056
Submission
- Device name
- Pediatric Intubation Circuit
- Applicant
- Ackrad Laboratories
Mchenry, IL, US - Received
- January 6, 1984
- Decision date
- February 10, 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
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| 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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Questions and answers
When was Pediatric Intubation Circuit cleared by the FDA?
Pediatric Intubation Circuit (K840056) received a 510(k) decision of Substantially Equivalent on February 10, 1984, 35 days after the submission was received.
What is the product code of K840056?
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.