FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASONIC QFM SYSTEM 1000
K Number: K811376
·
Decision Aug 13, 1981
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
9
Review Days
90
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
- ULTRASONIC QFM SYSTEM 1000
- K Number
- K811376
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Narco Bio-Systems
- Date Received
- May 15, 1981
- Decision Date
- August 13, 1981
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Elfor-L
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Narco Bio-Systems
| K Number | Device Name | ||
|---|---|---|---|
| K853683 | UMS-100 | Jan 10, 1986 | Substantially Equivalent |
| K833656 | NARCOTRACE 40 - NT40 | May 9, 1984 | Substantially Equivalent |
| K832869 | MOTILITY MEASUREMENT SYS MMS-100 | Oct 31, 1983 | Substantially Equivalent |
| K813502 | NARCO TELECARE ISOFLO PRESSURE MONITOR | Dec 29, 1981 | Substantially Equivalent |
| K810431 | NARCO TLECARE MINIATURE PRESSURE DOME | Mar 11, 1981 | Substantially Equivalent |
| K801544 | PORTA-FIB LPD | Jul 14, 1980 | Substantially Equivalent |
| K760084 | MONITOR, GSR (NB-401) | Jul 26, 1976 | Substantially Equivalent |
| K760083 | PHYSIOSCOPE | Jul 20, 1976 | Substantially Equivalent |