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510(k) K932812

EC 5R PLETHYSMOGRAPH by D. E. Hokanson, Inc. — Product Code JEH

K932812 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "EC 5R PLETHYSMOGRAPH". The FDA issued a decision of Substantially Equivalent on January 13, 1994. The device falls under product code JEH (Plethysmograph, Volume), a Class II device regulated under 21 CFR 868.1760. D. E. Hokanson, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1994
Date Received
June 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Volume
Device Class
Class II
Regulation Number
868.1760
Review Panel
AN
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)
  • K932852 — NON INVASIVE VASCULAR PROGRAM (February 4, 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)

Other clearances for product code JEH

  • K240706 — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); P (December 9, 2024)
  • K223818 — Model 9160 VitaloQUB (May 25, 2023)
  • K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (April 22, 2008)
  • K022636 — BODY BOX 5500 (January 13, 2003)
  • K960840 — C.E. VASCULAR MACHINE (March 28, 1997)
  • K953642 — AP-18 (December 12, 1995)
  • K951901 — MASTERSCREEN PFT BODY (July 31, 1995)
  • K936108 — MASTERSCREEN BODY (February 3, 1995)
  • K925040 — TELEPULSE (August 23, 1993)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)

FDA data resources