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510(k) K852102

COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM by Warren E. Collins, Inc. — Product Code CCM

K852102 is an FDA 510(k) premarket notification submitted by Warren E. Collins, Inc. for the device "COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM". The FDA issued a decision of Substantially Equivalent on July 31, 1985. The device falls under product code CCM (Plethysmograph, Pressure), a Class II device regulated under 21 CFR 868.1750. Warren E. Collins, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1985
Date Received
May 15, 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 Warren E. Collins, Inc.

  • K925459 — GS-MODULAR (GOLD STANDARD - MODULAR) (February 4, 1994)
  • K912946 — COLLINS DIGITAL PULMONARY MANOMETER (January 15, 1992)
  • K871151 — THE SPIRA ELEKTRO 2 (May 15, 1987)
  • K861227 — COLLINS PNEUMOTACH PFT SYSTEM (June 5, 1986)
  • K831780 — METABOLIC EXERCISE TESTING SYSTEM (September 12, 1983)
  • K831778 — RS-RESIDUAL VOLUME SYSTEM (August 31, 1983)
  • K831777 — COLLINS DS (August 31, 1983)
  • K831779 — COLLINS EAGLE II (August 26, 1983)
  • K803069 — SHELL KRATON THERMO-PLASTIC RUBBER COMP. (December 22, 1980)
  • K803053 — APEXLINE OF PULMONARY FUNCT. INSTRUM. (December 22, 1980)

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)
  • 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