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510(k) K863659

FLOW INTERRUPTION INDICATOR by Salter Labs — Product Code CCN

K863659 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "FLOW INTERRUPTION INDICATOR". The FDA issued a decision of Substantially Equivalent on October 15, 1986. The device falls under product code CCN (Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge), a Class I device regulated under 21 CFR 868.2300. Salter Labs has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1986
Date Received
September 18, 1986
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 Salter Labs

  • K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (July 30, 2026)
  • K190878 — Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-T (January 10, 2020)
  • K161719 — Salter Labs Bubble Humidifier (September 21, 2017)
  • K151874 — BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlo (April 15, 2016)
  • K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (March 11, 2016)
  • K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannul (March 10, 2016)
  • K143700 — CPAP Cannulaide (August 5, 2015)
  • K142416 — Luma Wrap (June 12, 2015)
  • K092685 — PNEUMOTHERML, MODEL: 5800 (November 24, 2009)
  • K051313 — BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER (September 15, 2005)

Other clearances for product code CCN

  • K934945 — FLOWMETER NIPPLE ADAPTOR (November 17, 1993)
  • K920783 — OXYGEN FLOW CONTROLLER (September 18, 1992)
  • K872038 — NEB-U-VENT (August 10, 1987)
  • K871262 — MODIFIED NOFLO I (July 21, 1987)
  • K863613 — NO-FLO I (December 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