Babyset(Tm) Modified Jackson-Rees Circuit W/Valve
FDA 510(k) K871669 · Life Design Systems, Inc.
510(k) numberK871669
Submission
- Device name
- Babyset(Tm) Modified Jackson-Rees Circuit W/Valve
- Applicant
- Life Design Systems, Inc.
Franklin, WI, US - Received
- April 28, 1987
- Decision date
- May 19, 1987
- 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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| K952009 | Prima Pediatric Temperature Monitoring CircuitsCAI · Traditional | Prima, Inc. | 05/19/1995SE |
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| 510(k) | Device | Decision |
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| K893030 | Child Size - Filter Flex (TM)CAH · Traditional | 09/18/1989SE |
| K892862 | Flex-Cup PercussorBYI · Traditional | 05/25/1989SE |
| K892221 | Pulmonary Resuscitator, ModificationBTM · Traditional | 05/18/1989SE |
| K890011 | Oxygen Connector and Oxygen Delivery TubingBZO · Traditional | 03/20/1989SE |
| K890108 | Modified Cushion-Flex(Tm)BSJ · Traditional | 01/24/1989SE |
| K884387 | Cushion Flex(Tm)BSJ · Traditional | 11/17/1988SE |
| K884068 | Pulmanex TM (Neo-Natal Size)BTM · Traditional | 11/16/1988SE |
| K873179 | Heater Wire Breathing CircuitBZE · Traditional | 03/31/1988SE |
Questions and answers
When was Babyset(Tm) Modified Jackson-Rees Circuit W/Valve cleared by the FDA?
Babyset(Tm) Modified Jackson-Rees Circuit W/Valve (K871669) received a 510(k) decision of Substantially Equivalent on May 19, 1987, 21 days after the submission was received.
What is the product code of K871669?
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.