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510(k) K870016

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) by Migada, Ltd. — Product Code DTB

K870016 is an FDA 510(k) premarket notification submitted by Migada, Ltd. for the device "ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)". The FDA issued a decision of Substantially Equivalent on May 28, 1987. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Migada, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1987
Date Received
January 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Permanent Pacemaker Electrode
Device Class
Class III
Regulation Number
870.3680
Review Panel
CV
Submission Type

Other clearances by Migada, Ltd.

  • K954883 — FREE FLOW SAFETY DEVICE (April 23, 1996)
  • K943095 — IV TRANSFER SPIKE (September 30, 1994)
  • K933929 — LAB-SITE(R) SAFETY CANNULA (December 7, 1993)
  • K902881 — LAB-SITE SAFETY NEEDLE (September 26, 1990)
  • K864453 — EMERGENCY & MILITARY INFUSION SYSTEM (January 20, 1987)
  • K863304 — PRESELECTED FLOW RATE I.V. SET (December 9, 1986)
  • K860952 — I.V. SET WITH AND WITHOUT AIR VENT (August 27, 1986)
  • K861275 — HIGH FLOW I.V. SET (June 2, 1986)
  • K860595 — TRANSFER SET (April 7, 1986)
  • K854365 — IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS (March 24, 1986)

Other clearances for product code DTB

  • K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS (July 10, 2006)
  • K041809 — PERMANENT PACING LEAD, MODEL PY2 (August 6, 2004)
  • K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (April 7, 2004)
  • K031274 — MODEL 5071 MYOCARDIAL PACING LEAD (May 22, 2003)
  • K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (May 16, 2003)
  • K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (April 24, 2003)
  • K024053 — PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (January 31, 2003)
  • K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (December 11, 2002)
  • K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (October 18, 2002)
  • K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (May 1, 2002)

FDA data resources