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FDA 510(k)

GEM PREMIER PLUS MODEL 5500

K-Number: K961335 · 1996-06-28

ApplicantMallinckrodt Sensor Systems, Inc.
Decision Date1996-06-28
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM PREMIER PLUS MODEL 5500 is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Sensor Systems, Inc.. It received FDA 510(k) clearance on 1996-06-28 under 510(k) number K961335. 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 GEM PREMIER PLUS MODEL 5500?

GEM PREMIER PLUS MODEL 5500 is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Mallinckrodt Sensor Systems, Inc.. The 510(k) number is K961335.

When did GEM PREMIER PLUS MODEL 5500 receive FDA 510(k) clearance?

GEM PREMIER PLUS MODEL 5500 received FDA 510(k) clearance on 1996-06-28, under 510(k) number K961335.

Who is the listed applicant for GEM PREMIER PLUS MODEL 5500?

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

What is the FDA product code for GEM PREMIER PLUS MODEL 5500?

The FDA product code for GEM PREMIER PLUS MODEL 5500 is CHL.

Related Clinical Trials

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.

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Other records listing Mallinckrodt Sensor Systems, Inc. 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.

K910305GEM-PREMIER SYSTEM

Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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