Life Design Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 29
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K913714 | MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) | December 1, 1992 |
| K885313 | HUMIDI-FLEX TM | October 11, 1989 |
| K893030 | CHILD SIZE - FILTER FLEX (TM) | September 18, 1989 |
| K892862 | FLEX-CUP PERCUSSOR | May 25, 1989 |
| K892221 | PULMONARY RESUSCITATOR, MODIFICATION | May 18, 1989 |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | March 20, 1989 |
| K890108 | MODIFIED CUSHION-FLEX(TM) | January 24, 1989 |
| K884387 | CUSHION FLEX(TM) | November 17, 1988 |
| K884068 | PULMANEX TM (NEO-NATAL SIZE) | November 16, 1988 |
| K873179 | HEATER WIRE BREATHING CIRCUIT | March 31, 1988 |
| K863857 | PULSE-OX | October 7, 1987 |
| K864681 | CARHILL ONE-WAY RESUSCITATION VALVE | May 21, 1987 |
| K871669 | BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE | May 19, 1987 |
| K862448 | FLOW GENERATOR FOR SLEEP APNEA, LDS 1500 | November 14, 1986 |
| K863026 | PULMANEX TM (MODIFICATION) | August 26, 1986 |
| K861758 | CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA | July 14, 1986 |
| K860659 | END TIDAL CO2 SAMPLING CIRCUIT | April 17, 1986 |
| K860693 | PULMANEX (TM) | March 27, 1986 |
| K854822 | LDS PEEP VALVE | February 24, 1986 |
| K854458 | CUSHION-FLEX TM-CPAP FACE MASK | January 15, 1986 |