FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELCH ALLYN FRONT-LINE DOC
K Number: K984215
·
Decision Feb 11, 1999
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
104
Review Days
79
Basic Information
- Device Name
- WELCH ALLYN FRONT-LINE DOC
- K Number
- K984215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WELCH ALLYN, INC.
- Date Received
- November 24, 1998
- Decision Date
- February 11, 1999
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
CustomSurg OrthoPlanner
FDA 510(k)
FDA Class 2
·Radiology
uOmniscan
FDA 510(k)
FDA Class 2
·Radiology
Mosaic (V1.0.1)
FDA 510(k)
FDA Class 2
·Radiology
UroNav 4
FDA 510(k)
FDA Class 2
·Radiology
TechLive
FDA 510(k)
FDA Class 2
·Radiology
SMARTDent
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by WELCH ALLYN, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Dec 19, 2014 | Substantially Equivalent |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | Jan 31, 2014 | Substantially Equivalent |
| K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR | Nov 20, 2013 | Substantially Equivalent |
| K131573 | CP150 ELECTROCARDIOGRAPH | Jul 3, 2013 | Substantially Equivalent |
| K121405 | PANOPTIC | Dec 20, 2012 | Substantially Equivalent |
| K122058 | FLEXIPORT ECOCUFF | Nov 5, 2012 | Substantially Equivalent |
| K121013 | CONNEX VITAL SIGNS MONITOR 6000 SERIES | Jul 26, 2012 | Substantially Equivalent |
| K120774 | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT | Apr 10, 2012 | Substantially Equivalent |
| K120743 | SPECULUM, VAGINAL, NONMETAL | Mar 23, 2012 | Substantially Equivalent |
| K120343 | CONNEX WORKSTATION | Feb 24, 2012 | Substantially Equivalent |