Perimed AB
Las Vegas, NV, US
PERIMED AB appears in FDA device records in Las Vegas, NV. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Perimed AB between 1989 and 2016. The busiest year on record is 1993, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152930 | PeriFlux6000 | DPW | Substantially Equivalent | |
| K131253 | PERIFLUX 6000 | LKD | Substantially Equivalent | |
| K120884 | PERICAM PSI | DPT | Substantially Equivalent | |
| K011899 | PF 5050 PRESSURE UNIT, MODEL PF 5050 | DPW | Substantially Equivalent | |
| K990960 | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) | LKD | Substantially Equivalent | |
| K974285 | PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT | DPW | Substantially Equivalent | |
| K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 | GEX | Substantially Equivalent | |
| K932068 | PERITEMP PF 4005 HEATER | DPW | Substantially Equivalent | |
| K922368 | PERIFLUX PF4001 LASER DOPPLER FLOWMETER | DPW | Substantially Equivalent | |
| K890828 | PERIFLUX PF3 | DPW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8030885 | 3003244961 | PERIMED AB | DATAVAGEN 9 A, JARFALLA Stockholm 17543 SE | 2026 | |
| 2246823 | 2246823 | PERIMED INC | 7485 W Azure Drive, Suite 126, Las Vegas, NV 89130 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain