FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERIFLUX PF3
K Number: K890828
·
Decision Jun 20, 1989
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
6
Review Days
119
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Basic Information
- Device Name
- PERIFLUX PF3
- K Number
- K890828
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Perimed, Inc.
- Date Received
- February 21, 1989
- Decision Date
- June 20, 1989
- 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 |
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Other Clearances by Perimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | Sep 23, 1999 | Substantially Equivalent |
| K974285 | PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT | May 28, 1998 | Substantially Equivalent |
| K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 | Apr 18, 1994 | Substantially Equivalent |
| K932068 | PERITEMP PF 4005 HEATER | Dec 7, 1993 | Substantially Equivalent |
| K922368 | PERIFLUX PF4001 LASER DOPPLER FLOWMETER | Feb 3, 1993 | Substantially Equivalent |