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510(k) K081823

MASTERSCREEN PAED - BABY BODY by Viasys Healthcare GmbH — Product Code CCM

K081823 is an FDA 510(k) premarket notification submitted by Viasys Healthcare GmbH for the device "MASTERSCREEN PAED - BABY BODY". The FDA issued a decision of Substantially Equivalent on May 18, 2009. The device falls under product code CCM (Plethysmograph, Pressure), a Class II device regulated under 21 CFR 868.1750. Viasys Healthcare GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2009
Date Received
June 27, 2008
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 Viasys Healthcare GmbH

  • K092324 — SPIROPRO (September 3, 2009)
  • K091412 — CLEAN PEAK FLOW METER (August 21, 2009)
  • K091505 — COR12+ (June 10, 2009)
  • K080510 — VIP PULMONARY FUNCTION SYSTEM (August 20, 2008)
  • K080734 — FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT (June 26, 2008)
  • K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (April 22, 2008)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)
  • K071753 — MASTERSCREEN PNEUMO & MASTERSCOPE (August 14, 2007)
  • K062011 — MODIFICATION TO FLOWSCREEN (May 11, 2007)
  • K070614 — CORSCREEN (May 4, 2007)

Other clearances for product code CCM

  • 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)
  • 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