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510(k) K852088

SYSTEM 1085 BODY PLETHYSMOGRAPH by Medical Graphics Corp. — Product Code CCM

K852088 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "SYSTEM 1085 BODY PLETHYSMOGRAPH". The FDA issued a decision of Substantially Equivalent on July 30, 1985. The device falls under product code CCM (Plethysmograph, Pressure), a Class II device regulated under 21 CFR 868.1750. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1985
Date Received
May 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Pressure
Device Class
Class II
Regulation Number
868.1750
Review Panel
AN
Submission Type

Other clearances by Medical Graphics Corp.

  • K152585 — Resmon PRO FULL (June 24, 2016)
  • K070858 — EXPRESS SERIES (April 16, 2007)
  • K061731 — MEDGRAPHICS ULTIMA SYSTEM (September 6, 2006)
  • K955432 — CPX, CCM, CATH WITH 15% CO2 (July 1, 1996)
  • K943259 — 1085 ULTIMATE E PLETHYSMOGRAPH (April 10, 1995)
  • K923209 — MEDGRAPHICS EXERCISE CONSULT (March 11, 1993)
  • K912906 — MEDGRAPHICS PF/DX (February 4, 1992)
  • K896345 — EXERCISE EVALUATION SYSTEM 2010 (January 20, 1990)
  • K896396 — MIDA SYSTEM, MODELS 1000/1100 (January 18, 1990)
  • K874925 — CPE 2000 CARDIO PULMONARY ERGOMETER (January 19, 1988)

Other clearances for product code CCM

  • K081823 — MASTERSCREEN PAED - BABY BODY (May 18, 2009)
  • K023796 — MS PAED-BABY BODY (March 3, 2003)
  • K943259 — 1085 ULTIMATE E PLETHYSMOGRAPH (April 10, 1995)
  • K893420 — MASTERLAB PFT AND MASTERLAB BODY BOX (June 23, 1989)
  • K853390 — INFANT BODY TEST (February 5, 1986)
  • K852102 — COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM (July 31, 1985)
  • K843851 — BODYSCREEN II (February 14, 1985)
  • K843846 — UNIVERSAL-BODYTEST (February 14, 1985)
  • K791705 — 4200 PNEUMATIC MOUTH SHUTTER (October 4, 1979)
  • K772367 — CHEST BELLOWS, SMALL (January 11, 1978)

FDA data resources