Penlon, Ltd.
FDA Regulatory Profile
Penlon, Ltd. appears in FDA public data with 1 recall, 19 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1653-2013, Class II) was initiated on May 14, 2013. Its most recent 510(k) clearance was granted on July 28, 2006.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1653-2013 | Class II | Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and delive | May 14, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K061102 | PRIMA ANAESTHESIA MACHINE | July 28, 2006 |
| K041076 | DELTA T | August 9, 2004 |
| K010317 | AV 800 VENTILATOR | July 23, 2001 |
| K010318 | PRIMA OXYGEN MONITOR | July 23, 2001 |
| K002343 | SIGMA DELTA | June 8, 2001 |
| K961468 | QUIK-FIL VAPORIZER KEYED FILLER | July 16, 1996 |
| K960944 | PPV VAPORIZER (MODIFICATION) | April 2, 1996 |
| K953179 | CLM LARYNGOSCOPE | October 6, 1995 |
| K942545 | SIGMA ELITE | February 3, 1995 |
| K936046 | SIGMA ELITE | November 4, 1994 |
| K902381 | PENLON BREATHING SYSTEM PRESSURE MONITOR | August 17, 1990 |
| K894689 | PENLON IDP PRESSURE FAILURE ALARM | August 10, 1989 |
| K844007 | PENLON PPV VAPORIZER | March 12, 1985 |
| K844008 | PENLON AM1000 ANAESTHESIA MACHINE | March 12, 1985 |
| K823555 | MAGTARAK RESPIRATORY MONITOR & FLOW SENS | January 5, 1983 |
| K803052 | NUFFIELD ANESTHESIA VENTILATOR SER. 400 | January 7, 1981 |
| K801253 | CREST ELECTRONIC WARMING BLANKET | January 2, 1981 |
| K801254 | PENLON I.D.P. PRESSSURE FAILURE ALARM | June 9, 1980 |
| K801255 | PENLON JUMBO CARBON DIOXIDE ABSORBER | June 4, 1980 |