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510(k) K843851

BODYSCREEN II by Erich Jaeger, Inc. — Product Code CCM

K843851 is an FDA 510(k) premarket notification submitted by Erich Jaeger, Inc. for the device "BODYSCREEN II". The FDA issued a decision of Substantially Equivalent on February 14, 1985. The device falls under product code CCM (Plethysmograph, Pressure), a Class II device regulated under 21 CFR 868.1750. Erich Jaeger, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1985
Date Received
October 1, 1984
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 Erich Jaeger, Inc.

  • K023120 — OXYCON MOBILE (November 12, 2003)
  • K023796 — MS PAED-BABY BODY (March 3, 2003)
  • K021138 — SLEEPSCREEN/APNOESCREEN CARDIO (February 12, 2003)
  • K000396 — APNOESCREEN PRO, ALPHA SCREEN PRO (December 27, 2000)
  • K001502 — AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO (July 12, 2000)
  • K000648 — SPIRO PRO (March 29, 2000)
  • K992214 — OXYCON PRO (February 22, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K980094 — MODIFICATION TO THE OXYCONALPHA (July 28, 1998)
  • K972419 — TOENNIES NEUROSCREEN SYSTEM (April 30, 1998)

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)
  • K852088 — SYSTEM 1085 BODY PLETHYSMOGRAPH (July 30, 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