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510(k) K852632

GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB by Medicomp, Inc. — Product Code CAI

K852632 is an FDA 510(k) premarket notification submitted by Medicomp, Inc. for the device "GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB". The FDA issued a decision of Substantially Equivalent on January 3, 1986. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Medicomp, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1986
Date Received
June 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device Class
Class I
Regulation Number
868.5240
Review Panel
AN
Submission Type

Other clearances by Medicomp, Inc.

  • K173170 — Epicardia Anywhere (January 10, 2018)
  • K161916 — TelePatch Cardiac Monitor (December 21, 2016)
  • K091696 — SAVI WIRELESS, MODEL PM500 (October 26, 2009)
  • K090834 — EPICARDIA 5000 (May 15, 2009)
  • K043454 — CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 (March 24, 2005)
  • K981119 — CARDIOPAL MODEL NUMBER PM20 (October 14, 1998)
  • K952846 — EPICARDIA (September 18, 1995)
  • K943915 — HEAT AND MOISTURE EXCHANGER FILTER (HME) (October 14, 1994)
  • K900207 — EPICARDIA 4000 (July 31, 1990)
  • K883103 — EPICARDIA PC/FC (September 22, 1988)

Other clearances for product code CAI

  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (September 19, 1995)
  • K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (September 19, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources