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510(k) K911264

CALIBRATION KIT by S & W Medico Teknik — Product Code BXK

K911264 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "CALIBRATION KIT". The FDA issued a decision of Substantially Equivalent on August 2, 1991. The device falls under product code BXK (Gas, Calibration (Specified Concentration)), a Class I device regulated under 21 CFR 868.6400. S & W Medico Teknik has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1991
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas, Calibration (Specified Concentration)
Device Class
Class I
Regulation Number
868.6400
Review Panel
AN
Submission Type

Other clearances by S & W Medico Teknik

  • K964593 — DIASCOPE TRAVELLER PLUS (4053) (June 30, 1997)
  • K940933 — 9267 SPO2 ATHENA MODULE (November 29, 1995)
  • K942196 — 3050 DIASCOPE NT PATIENT MONITOR (June 28, 1995)
  • K913013 — TCPO2 9260 MODULE - SYSTEM ATHENA (May 3, 1994)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K915633 — MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA (June 29, 1993)
  • K930134 — 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT (April 9, 1993)
  • K923418 — 9293/1 INTERFACE MODULE (February 23, 1993)
  • K911611 — SYSTEM ATHENA, MODIFICATION (February 5, 1993)
  • K922314 — VENTILATOR INTERFACE 9291/4 (December 17, 1992)

Other clearances for product code BXK

  • K954803 — BLOOD GAS MIXTURES (January 25, 1996)
  • K954804 — LUNG DIFFUSION MIXTURES (January 25, 1996)
  • K954542 — LUNG DIFFUSION MIXTURE (December 22, 1995)
  • K952838 — MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES (September 19, 1995)
  • K953934 — MED-TECH LUNG DIFFUSION MIXTURE (September 18, 1995)
  • K953208 — MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES (July 20, 1995)
  • K944998 — CALIBRATION GAS (February 3, 1995)
  • K944812 — CLINICAL BLOOD GAS MIXTURE (February 1, 1995)
  • K942866 — CLINICAL BLOOD GAS MIXTURE (September 1, 1994)
  • K932874 — BLOOD GAS MIXTURE (January 27, 1994)

FDA data resources