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510(k) K780750

O2 CONNECTOR by Diemolding Corp. — Product Code CAN

K780750 is an FDA 510(k) premarket notification submitted by Diemolding Corp. for the device "O2 CONNECTOR". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
May 8, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type

Other clearances by Diemolding Corp.

  • K962749 — THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PO (October 10, 1996)
  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K902713 — ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS (July 25, 1990)
  • K902114 — CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR (July 18, 1990)
  • K900754 — RESPIREX 2 (March 15, 1990)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K781759 — RESCAL (November 27, 1978)
  • K770369 — VACON TM (March 1, 1977)
  • K760931 — I.V. DRIP MONITOR ALARM DEVICE, MONIFLO (January 5, 1977)
  • K760636 — ORTHOMIX (October 5, 1976)

Other clearances for product code CAN

  • K162811 — MR Conditional CGA 870 (March 2, 2017)
  • K080243 — PORTABLE OXYGEN UNIT SCA900 (April 7, 2009)
  • K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (October 25, 2006)
  • K061785 — CYL-FIL OXYGEN SYSTEM (September 7, 2006)
  • K950777 — OXYGEN REGULATOR (April 14, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932006 — 1500 SERIES REGULATOR (October 25, 1993)
  • K921125 — AMBU OXYGEN REGULATOR (September 17, 1992)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)

FDA data resources