510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K833430Substantially Equivalent

Blood Gas Expersystem 8700

Medical Intelcom, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833430 is the FDA 510(k) clearance record for BLOOD GAS EXPERSYSTEM 8700, a class III device, cleared for Medical Intelcom, Inc. on under FDA product code LLE (Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease). FDA records list one 510(k) clearance for Medical Intelcom, Inc. As of , FDA records show no recalls naming K833430.

Clearance record

Decision date
Received
(128 days to decision)
Product code
LLE Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
Device class
Class III
Review panel
Unknown
Applicant
Medical Intelcom, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LLE

Trailing 12 months

FDA records hold no clearances under product code LLE in the trailing twelve months.

FDA records show no clearances under product code LLE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260