VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
FDA 510(k) clearance K140339 · decided 2014-04-10
Clearance details
- K-number
- K140339
- Device name
- VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2014-02-10
- Decision date
- 2014-04-10
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically con recall (Z-2234-2014) | Nellcor Puritan Bennett Inc. (dba Covidien LP) | 2014-08-14 |
| Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronicall recall (Z-2235-2014) | Nellcor Puritan Bennett Inc. (dba Covidien LP) | 2014-08-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006) | Covidien | 1997-06-24 |
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005) | Covidien | 1995-12-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004) | Covidien | 1995-06-14 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003) | Covidien | 1994-06-17 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002) | Covidien | 1994-03-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001) | Covidien | 1993-09-10 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034) | Covidien | 1991-12-13 |