22MM Id/Od Adapter
FDA 510(k) K911263 · Monaghan Medical Corp.
510(k) numberK911263
Submission
- Device name
- 22MM Id/Od Adapter
- Applicant
- Monaghan Medical Corp.
Plattsburgh, NY, US - Received
- March 22, 1991
- Decision date
- August 19, 1991
- 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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| 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 22MM Id/Od Adapter cleared by the FDA?
22MM Id/Od Adapter (K911263) received a 510(k) decision of Substantially Equivalent on August 19, 1991, 150 days after the submission was received.
What is the product code of K911263?
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.