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510(k) K953642

AP-18 by Jeneric/Pentron, Inc. — Product Code JEH

K953642 is an FDA 510(k) premarket notification submitted by Jeneric/Pentron, Inc. for the device "AP-18". The FDA issued a decision of Substantially Equivalent on December 12, 1995. The device falls under product code JEH (Plethysmograph, Volume), a Class II device regulated under 21 CFR 868.1760. Jeneric/Pentron, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1995
Date Received
August 4, 1995
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 Jeneric/Pentron, Inc.

  • K020499 — BOND-3 ADHESIVE (April 22, 2002)
  • K013543 — BOND-1 C & B (February 22, 2002)
  • K013542 — DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) (February 14, 2002)
  • K012231 — AVANTE MICRO CRYSTAL SYSTEM (August 23, 2001)
  • K011748 — FIRST FILL R.C.S. (August 3, 2001)
  • K010957 — QUELL DESENSITIZER (June 25, 2001)
  • K011331 — JP CAST 40 (June 22, 2001)
  • K011330 — JP CAST 50 (June 22, 2001)
  • K011362 — GOLD CORE 73 LS (May 29, 2001)
  • K010044 — COSMIC (February 9, 2001)

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)
  • K951901 — MASTERSCREEN PFT BODY (July 31, 1995)
  • K936108 — MASTERSCREEN BODY (February 3, 1995)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K925040 — TELEPULSE (August 23, 1993)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)

FDA data resources