Home / 510(k) Clearances / K843212

510(k) K843212

LOW PRESSURE ALARM FOR OXYGEN CYLINDER by Hospitak, Inc. — Product Code BXH

K843212 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "LOW PRESSURE ALARM FOR OXYGEN CYLINDER". The FDA issued a decision of Substantially Equivalent on September 19, 1984. The device falls under product code BXH (Gauge, Gas Pressure, Cylinder/Pipeline), a Class I device regulated under 21 CFR 868.2610. Hospitak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1984
Date Received
August 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Gas Pressure, Cylinder/Pipeline
Device Class
Class I
Regulation Number
868.2610
Review Panel
AN
Submission Type

Other clearances by Hospitak, Inc.

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K954787 — ILLUMINATOR (January 31, 1996)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K915750 — DISPOSABLE BACTERIAL BREATHNG FILTER (November 30, 1994)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)
  • K915228 — DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL (February 11, 1992)
  • K873286 — DISPOSABLE, MANUAL PULMONARY RESUSCITATOR (October 26, 1987)
  • K853600 — INFLATABLE AIR SPLINTS (September 19, 1985)
  • K844328 — OXYGEN CONCENTRATOR (December 4, 1984)

Other clearances for product code BXH

  • K942645 — B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG (July 27, 1994)
  • K853040 — PRESSURE GAUGE (October 10, 1985)
  • K770614 — MONITOR, GAS MANIFOLD (April 7, 1977)

FDA data resources