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510(k) K883988

NON-REBREATHING TEE PIECE (NRTP) by Dhd Medical Products Div. Diemolding Corp. — Product Code CBP

K883988 is an FDA 510(k) premarket notification submitted by Dhd Medical Products Div. Diemolding Corp. for the device "NON-REBREATHING TEE PIECE (NRTP)". The FDA issued a decision of Substantially Equivalent on October 7, 1988. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Dhd Medical Products Div. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1988
Date Received
September 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

Other clearances by Dhd Medical Products Div. Diemolding Corp.

  • K881935 — MICROCIRRUS MEDICAL NEBULIZER (June 22, 1988)
  • K881178 — CUFFCHECK (April 14, 1988)
  • K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (March 9, 1988)
  • K874047 — ASTHMAKIT (February 29, 1988)
  • K873447 — DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (October 30, 1987)
  • K860885 — STRAIGHT CONNECTORS, 15MM, 30MM & 19MM (March 20, 1986)
  • K860879 — DISPOSABLE VENTILATOR CIRCUITS (March 20, 1986)
  • K860882 — DISPOSABLE CATHETER (March 20, 1986)
  • K860877 — FLEXTUBE, CONNECTING TUBING (March 20, 1986)
  • K860875 — CIRRUS DRUG NEBULIZER MK III (March 20, 1986)

Other clearances for product code CBP

  • K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MT (October 29, 2024)
  • K234053 — F&P Optiflow Flow Diverter (August 9, 2024)
  • K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb) (December 23, 2021)
  • K192285 — CPR Face Shield (November 25, 2020)
  • K173770 — OJR215 Pressure Relief Manifold (April 5, 2019)
  • K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo (November 17, 2017)
  • K152521 — Seal Rite Non-Rebreathing Valve (June 3, 2016)
  • K142764 — KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (July 9, 2015)
  • K142402 — BigEasy Non-Rebreathing Valve (March 23, 2015)
  • K132143 — EXHALATION VALVE (June 4, 2014)

FDA data resources