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510(k) K925040

TELEPULSE by Biometrix , Ltd. — Product Code JEH

K925040 is an FDA 510(k) premarket notification submitted by Biometrix , Ltd. for the device "TELEPULSE". The FDA issued a decision of Substantially Equivalent on August 23, 1993. The device falls under product code JEH (Plethysmograph, Volume), a Class II device regulated under 21 CFR 868.1760. Biometrix , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1993
Date Received
October 5, 1992
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 Biometrix , Ltd.

  • K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pre (September 4, 2015)
  • K011216 — PVC FREE INTRAVASCULAR ADMINISTRATION SET (July 18, 2001)
  • K001461 — TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET (September 11, 2000)

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)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)

FDA data resources