Unknown

FDA 510(k) K837224 · Xanar, Inc.

Substantially Equivalent

510(k) numberK837224

Submission

Device name
Unknown
Applicant
Xanar, Inc.
Colorado Springs, CO, US
Received
March 2, 1983
Decision date
May 2, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

More from Xanar, Inc.

510(k)DeviceDecision
K861688Xanar CO2 Surgical Laser System Model XAP-15GEX · Traditional 10/03/1986SE
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K860496Model NY-110 for Upper & Lower (Gu) & PulmonaryLNK · Traditional 03/14/1986SE
K853620Model XA-50 - CO2 Surgical LaserGEX · Traditional 01/24/1986SE
K850818Co 2 Surgical Laser System NA-120GEX · Traditional 08/15/1985SE
K850805Co 2 Surgical Laser System Model NA-40GEX · Traditional 08/15/1985SE
K850804Co 2 Surgical Laser System NA-30GEX · Traditional 08/15/1985SE
K844087Xanar Model XSE-300 Smoke EvaculaterFYD · Traditional 02/27/1985SE
K841860CO2 Surgical Laser System XML-10EWG · Traditional 11/08/1984SE
K833325Ambulase XAM-15 Xanar Surg. Laser · Traditional 01/26/1984SE

Questions and answers

When was Unknown cleared by the FDA?

Unknown (K837224) received a 510(k) decision of Substantially Equivalent on May 2, 1983, 61 days after the submission was received.