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510(k) K022636

BODY BOX 5500 by Morgan Scientific, Inc. — Product Code JEH

K022636 is an FDA 510(k) premarket notification submitted by Morgan Scientific, Inc. for the device "BODY BOX 5500". The FDA issued a decision of Substantially Equivalent on January 13, 2003. The device falls under product code JEH (Plethysmograph, Volume), a Class II device regulated under 21 CFR 868.1760. Morgan Scientific, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2003
Date Received
August 8, 2002
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 Morgan Scientific, Inc.

  • K213872 — ComPAS2 (July 15, 2022)
  • K190568 — ComPAS2 (Computerized Pulmonary Analysis System) (June 6, 2019)
  • K042595 — SPIRO'AIR (May 4, 2005)
  • K021200 — COMPAS (October 18, 2002)
  • K013752 — COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) (January 30, 2002)

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)
  • 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)
  • K925040 — TELEPULSE (August 23, 1993)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)

FDA data resources