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510(k) K023796

MS PAED-BABY BODY by Erich Jaeger GmbH — Product Code CCM

K023796 is an FDA 510(k) premarket notification submitted by Erich Jaeger GmbH for the device "MS PAED-BABY BODY". The FDA issued a decision of Substantially Equivalent on March 3, 2003. The device falls under product code CCM (Plethysmograph, Pressure), a Class II device regulated under 21 CFR 868.1750. Erich Jaeger GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2003
Date Received
November 13, 2002
Clearance Type
Special
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 GmbH

  • K023120 — OXYCON MOBILE (November 12, 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)
  • K960078 — ASTHMA MONITOR (September 20, 1996)

Other clearances for product code CCM

  • K081823 — MASTERSCREEN PAED - BABY BODY (May 18, 2009)
  • 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)
  • 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