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510(k) K833966

PUMP INFUSION WEARABLE INFUSION PUMP by Oximetrix, Inc. — Product Code JSJ

K833966 is an FDA 510(k) premarket notification submitted by Oximetrix, Inc. for the device "PUMP INFUSION WEARABLE INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on Jan 25, 1984. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Oximetrix, Inc. has 11 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 25, 1984
Date Received
Nov 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type
510(k) Exempt

Other clearances by Oximetrix, Inc.

  • K853018 — MODEL 3000 OPTICATH COMPUTER (Jan 13, 1986)
  • K842622 — HEMO STATIC/ESU SCALPEL SYSTEM (Oct 23, 1984)
  • K823007 — OPTICATH HEPARIN COATED, FLOW-DIRECT (Nov 1, 1982)
  • K821056 — FLOW DIRECTED THERMAL-DILUTION CATHETER (May 18, 1982)
  • K821057 — FLOW DIRECTED THERMAL-DILUTION INFUSION (May 18, 1982)
  • K820674 — OPTICATH (Mar 25, 1982)
  • K811391 — OXIMETRIX ACCU SAT CPB (Jul 20, 1981)
  • K791868 — OXIMETRIX SHAW HEMOSTATIC SURG. SYS. (Jan 4, 1980)
  • K781879 — HEATER, OXIMETER SYSTEM (Jan 8, 1979)
  • K781134 — CATHETER, THERMAL DILUTION FIBEROPTIC (Aug 17, 1978)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (Jun 22, 1988)
  • K881561 — TERGITOL 7 BROTH (Apr 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (Apr 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (Apr 18, 1988)
  • K881578 — STREPTOSEL (Apr 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (Apr 18, 1988)
  • K881544 — LITTMAN AGAR (Apr 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (Apr 18, 1988)
  • K881571 — YM BROTH (Apr 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (Apr 18, 1988)

FDA data resources