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FDA 510(k)

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

K-Number: K870016 · 1987-05-28

ApplicantMigada, Ltd.
Decision Date1987-05-28
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) is the device name listed in this FDA 510(k) record. The listed applicant is Migada, Ltd.. It received FDA 510(k) clearance on 1987-05-28 under 510(k) number K870016. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)?

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) is a medical device that received FDA 510(k) clearance on 1987-05-28. The listed applicant is Migada, Ltd.. The 510(k) number is K870016.

When did ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) receive FDA 510(k) clearance?

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) received FDA 510(k) clearance on 1987-05-28, under 510(k) number K870016.

Who is the listed applicant for ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)?

The FDA 510(k) record lists Migada, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)?

The FDA product code for ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) is DTB.

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Other records listing Migada, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K943095IV TRANSFER SPIKEK933929LAB-SITE(R) SAFETY CANNULAK902881LAB-SITE SAFETY NEEDLEK864453EMERGENCY & MILITARY INFUSION SYSTEMK863304PRESELECTED FLOW RATE I.V. SETK860952I.V. SET WITH AND WITHOUT AIR VENT

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Related Devices (Code: DTB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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