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FDA 510(k)

ABL SYSTEM 625, 615, 605

K-Number: K954612 · 1995-11-09

ApplicantRadiometer America, Inc.
Decision Date1995-11-09
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL SYSTEM 625, 615, 605 is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K954612. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL SYSTEM 625, 615, 605?

ABL SYSTEM 625, 615, 605 is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Radiometer America, Inc.. The 510(k) number is K954612.

When did ABL SYSTEM 625, 615, 605 receive FDA 510(k) clearance?

ABL SYSTEM 625, 615, 605 received FDA 510(k) clearance on 1995-11-09, under 510(k) number K954612.

Who is the listed applicant for ABL SYSTEM 625, 615, 605?

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

What is the FDA product code for ABL SYSTEM 625, 615, 605?

The FDA product code for ABL SYSTEM 625, 615, 605 is CHL.

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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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