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510(k) K872038

NEB-U-VENT by Design Technologies, Inc. — Product Code CCN

K872038 is an FDA 510(k) premarket notification submitted by Design Technologies, Inc. for the device "NEB-U-VENT". The FDA issued a decision of Substantially Equivalent on August 10, 1987. The device falls under product code CCN (Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge), a Class I device regulated under 21 CFR 868.2300. Design Technologies, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1987
Date Received
May 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Device Class
Class I
Regulation Number
868.2300
Review Panel
AN
Submission Type

Other clearances by Design Technologies, Inc.

  • K872358 — STA-PUT (August 6, 1987)
  • K871262 — MODIFIED NOFLO I (July 21, 1987)
  • K863613 — NO-FLO I (December 15, 1986)

Other clearances for product code CCN

  • K934945 — FLOWMETER NIPPLE ADAPTOR (November 17, 1993)
  • K920783 — OXYGEN FLOW CONTROLLER (September 18, 1992)
  • K871262 — MODIFIED NOFLO I (July 21, 1987)
  • K863613 — NO-FLO I (December 15, 1986)
  • K863659 — FLOW INTERRUPTION INDICATOR (October 15, 1986)
  • K863657 — OXYGEN CONSERVATOR (October 15, 1986)
  • K823775 — BORDON GAGE REGULATOR #BG (January 14, 1983)
  • K802037 — VITAMIN B12 FOLATE RADIOASSAY (November 21, 1980)

FDA data resources