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510(k) K951901

MASTERSCREEN PFT BODY by Erich Jaeger GmbH & Co. KG — Product Code JEH

K951901 is an FDA 510(k) premarket notification submitted by Erich Jaeger GmbH & Co. KG for the device "MASTERSCREEN PFT BODY". The FDA issued a decision of Substantially Equivalent on July 31, 1995. The device falls under product code JEH (Plethysmograph, Volume), a Class II device regulated under 21 CFR 868.1760. Erich Jaeger GmbH & Co. KG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
April 24, 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 Erich Jaeger GmbH & Co. KG

  • K980876 — ASTHMA MONITOR AM2 (August 14, 1998)
  • K954140 — MASTERSCREEN IOS (December 14, 1995)
  • K936108 — MASTERSCREEN BODY (February 3, 1995)

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)
  • 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