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510(k) K925893

OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT by Oem Medical Div. — Product Code CAI

K925893 is an FDA 510(k) premarket notification submitted by Oem Medical Div. for the device "OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on March 12, 1993. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Oem Medical Div. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1993
Date Received
November 17, 1992
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 Oem Medical Div.

  • K924570 — OEM MULTI-VAC POWERED SUCTION PUMP (August 5, 1993)
  • K922748 — GUEDEL AIRWAY (July 10, 1992)
  • K811855 — SKIN SCRUB KITS (July 31, 1981)
  • K761297 — MOUTHPIECE SEAL (January 3, 1977)

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)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources