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FDA 510(k)

SAFESTRIP

K-Number: K955107 · 1996-08-16

ApplicantFirehouse Medical, Inc.
Decision Date1996-08-16
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAFESTRIP is the device name listed in this FDA 510(k) record. The listed applicant is Firehouse Medical, Inc.. It received FDA 510(k) clearance on 1996-08-16 under 510(k) number K955107. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFESTRIP?

SAFESTRIP is a medical device that received FDA 510(k) clearance on 1996-08-16. The listed applicant is Firehouse Medical, Inc.. The 510(k) number is K955107.

When did SAFESTRIP receive FDA 510(k) clearance?

SAFESTRIP received FDA 510(k) clearance on 1996-08-16, under 510(k) number K955107.

Who is the listed applicant for SAFESTRIP?

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

What is the FDA product code for SAFESTRIP?

The FDA product code for SAFESTRIP is CGA.

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Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ 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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