Life Design Systems, Inc.
Medical device manufacturer in Carrollton, TX.
29510(k) clearances
0PMA approvals
0recalls
Device types
- BTM Ventilator, Emergency, Manual (Resuscitator) 7
- CAI Circuit, Breathing (W Connector, Adaptor, Y… 3
- BSJ Mask, Gas, Anesthetic 3
- BYE Attachment, Breathing, Positive End… 3
- CAH Filter, Bacterial, Breathing-Circuit 2
- BZO Set, Tubing And Support, Ventilator (W… 2
- DRX Electrode, Electrocardiograph 1
- BTC Bag, Reservoir 1
- BTK Strap, Head, Gas Mask 1
- BZD Ventilator, Non-Continuous (Respirator) 1
- CBP Valve, Non-Rebreathing 1
- DQA Oximeter 1
- BZE Heater, Breathing System W/Wo Controller… 1
- BYI Percussor, Powered-Electric 1
- BYD Condenser, Heat And Moisture (Artificial… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K913714 | Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional | 12/01/1992SE |
| K885313 | Humidi-Flex TMBYD · Traditional | 10/11/1989SE |
| 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 |
| K863857 | Pulse-OxDQA · Traditional | 10/07/1987SE |
| K864681 | Carhill One-Way Resuscitation ValveCBP · Traditional | 05/21/1987SE |
| K871669 | Babyset(Tm) Modified Jackson-Rees Circuit W/ValveCAI · Traditional | 05/19/1987SE |
| K862448 | Flow Generator for Sleep Apnea, LDS 1500BZD · Traditional | 11/14/1986SE |
| K863026 | Pulmanex TM (Modification)BTM · Traditional | 08/26/1986SE |
| K861758 | Cushion-Flex TM Nasal CPAP Mask for Sleep ApneaBYE · Traditional | 07/14/1986SE |
| K860659 | End Tidal CO2 Sampling CircuitBZO · Traditional | 04/17/1986SE |
| K860693 | Pulmanex (TM)BTM · Traditional | 03/27/1986SE |
| K854822 | LDS Peep ValveBYE · Traditional | 02/24/1986SE |
| K854458 | Cushion-Flex Tm-Cpap Face MaskBYE · Traditional | 01/15/1986SE |
| K854537 | HeadstrapBTK · Traditional | 12/03/1985SE |
| K854037 | PulmanexBTM · Traditional | 11/01/1985SE |
| K844729 | Resuscitator, Pulmonary, ManualBTM · Traditional | 03/25/1985SE |
| K843169 | Cushion-Flex TMBSJ · Traditional | 08/20/1984SE |
| K841264 | Babyset TM & Pac TM -Pulmonary AssistCAI · Traditional | 06/15/1984SE |
| K841236 | Filter-FlexCAH · Traditional | 04/05/1984SE |
| K822116 | Anesthesia Breathing Bag, Various SizesBTC · Traditional | 08/16/1982SE |
| K821846 | LDS Monitoring ElectrodeDRX · Traditional | 07/30/1982SE |
| K821087 | Anesthesia Breathing CircuitCAI · Traditional | 05/14/1982SE |