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510(k) K932852

NON INVASIVE VASCULAR PROGRAM by D. E. Hokanson, Inc. — Product Code JOB

K932852 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "NON INVASIVE VASCULAR PROGRAM". The FDA issued a decision of Substantially Equivalent on February 4, 1994. The device falls under product code JOB (Hexane Extraction, Fluorescence, Vitamin E), a Class I device regulated under 21 CFR 862.1815. D. E. Hokanson, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1994
Date Received
June 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexane Extraction, Fluorescence, Vitamin E
Device Class
Class I
Regulation Number
862.1815
Review Panel
CH
Submission Type

Other clearances by D. E. Hokanson, Inc.

  • K041689 — POLYURETHANE BLOOD PRESSURE CUFFS (August 6, 2004)
  • K033156 — OB1 OBSTETRICAL DOPPLER (December 9, 2003)
  • K023707 — A16 BLOOD FLOW MEASUREMENT SYSTEM (February 12, 2003)
  • K982707 — EC6 PLETHYSMOGRAPH (August 26, 1998)
  • K973426 — ANS 2000 ECG MONITOR AND RESPIRATION PACER (August 12, 1998)
  • K970570 — NIVP3 (WINDOWS VERSION OF NIVP (October 3, 1997)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K932851 — DISPOSABLE PENILE BLOOD PRESSURE CUFFS (November 15, 1993)
  • K905367 — E-20 RAPID CUFF INFLATOR (March 6, 1991)
  • K901592 — MODEL MD-5 DOPPLER (October 22, 1990)

FDA data resources