Welch Allyn Protocol, Inc
FDA Regulatory Profile
Welch Allyn Protocol, Inc appears in FDA public data with 1 recall, 7 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0633-2014, Class II) was initiated on November 21, 2013. Its most recent 510(k) clearance was granted on March 23, 2007.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0633-2014 | Class II | The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are ind | November 21, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K070204 | LINK TO ACUITY CLINICIAN NOTIFIER | March 23, 2007 |
| K063419 | MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) | December 4, 2006 |
| K033378 | VITAL SIGNS MONITOR, PROPAQ LT | March 1, 2004 |
| K031740 | VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES | August 26, 2003 |
| K022453 | MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM | August 21, 2002 |
| K021681 | MICROPAQ, MODELS 402, 404 | July 23, 2002 |
| K012451 | PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 | August 20, 2001 |