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510(k) K040317

IVC SYSTEM by Mark H. Friedman — Product Code ILO

K040317 is an FDA 510(k) premarket notification submitted by Mark H. Friedman for the device "IVC SYSTEM". The FDA issued a decision of Substantially Equivalent on May 7, 2004. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Mark H. Friedman has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2004
Date Received
February 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type

Other clearances by Mark H. Friedman

  • K955529 — CRYTRON SYSTEM (June 10, 1996)

Other clearances for product code ILO

  • K213097 — Armory Motion (June 10, 2022)
  • K083008 — COOLSKIN (June 10, 2009)
  • K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
  • K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE (September 7, 2007)
  • K070402 — MODIFICATION TO POLAR CARE 500 (March 29, 2007)
  • K973023 — INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET (November 3, 1997)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)
  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)
  • K964710 — BLEDSOE COLD CONTROL (May 9, 1997)

FDA data resources