Pericam Psi
FDA 510(k) K120884 · Perimed AB
510(k) numberK120884
Submission
- Device name
- Pericam Psi
- Applicant
- Perimed AB
Jarfalla, SE - Received
- March 23, 2012
- Decision date
- July 3, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPT – Probe, Blood-Flow, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2120
- Specialty
- Cardiovascular
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| K123216 | Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…DPT · Traditional | Aimago SA | 02/07/2013SE |
| K122943 | MOORFLPI-2 Full-Field Laser Perfusion ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/03/2013SE |
More from Moor Instruments, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K152930 | PeriFlux6000DPW · Traditional | 05/05/2016SE |
| K131253 | Periflux 6000LKD · Abbreviated | 10/22/2013SE |
| K011899 | PF 5050 Pressure Unit, Model PF 5050DPW · Traditional | 11/06/2001SE |
| K990960 | Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040)LKD · Traditional | 09/23/1999SE |
| K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF…DPW · Traditional | 05/28/1998SE |
| K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2GEX · Traditional | 04/18/1994SE |
| K932068 | Peritemp PF 4005 HeaterDPW · Traditional | 12/07/1993SE |
| K922368 | Periflux PF4001 Laser Doppler FlowmeterDPW · Traditional | 02/03/1993SE |
| K890828 | Periflux PF3DPW · Traditional | 06/20/1989SE |
Questions and answers
When was Pericam Psi cleared by the FDA?
Pericam Psi (K120884) received a 510(k) decision of Substantially Equivalent on July 3, 2012, 102 days after the submission was received.
What is the product code of K120884?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.