FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K3 COMPUTER SYSTEMS
K Number: K902977
·
Decision Apr 28, 1992
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
47
Applicant Total
1
Review Days
662
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- K3 COMPUTER SYSTEMS
- K Number
- K902977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Donald L. King M.D.
- Date Received
- July 6, 1990
- Decision Date
- April 28, 1992
- Product Code
- DPT
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPT), ordered by most recent decision date.
Laser Speckle Imaging System (RFLSI CZW)
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
FDA 510(k)
FDA Class 2
·Cardiovascular
Deltex Medical KDP72 Doppler Probe
FDA 510(k)
FDA Class 2
·Cardiovascular
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIO-PROBE TRANSDUCER (ADULT)
FDA 510(k)
FDA Class 2
·Cardiovascular