Cleared Traditional

K912626 - BOLUS XENON CIRCUIT
(FDA 510(k) Clearance)

K912626 · Vital Signs, Inc. · Radiology device

Aug 1991

Decision

50d

Days

Class 2

Risk

K912626 is an FDA 510(k) clearance for the BOLUS XENON CIRCUIT. This device is classified as a System, Rebreathing, Radionuclide (Class II - Special Controls, product code IYT).

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on August 2, 1991, 50 days after receiving the submission on June 13, 1991.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1390.

Submission Details

510(k) Number	K912626 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 13, 1991
Decision Date	August 02, 1991
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement