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FDA 510(k)

CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM

K-Number: K943097 · 1994-12-23

ApplicantGlobal Medical Technologies, Inc.
Decision Date1994-12-23
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Global Medical Technologies, Inc.. It received FDA 510(k) clearance on 1994-12-23 under 510(k) number K943097. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM?

CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-23. The listed applicant is Global Medical Technologies, Inc.. The 510(k) number is K943097.

When did CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM receive FDA 510(k) clearance?

CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM received FDA 510(k) clearance on 1994-12-23, under 510(k) number K943097.

Who is the listed applicant for CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM?

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

What is the FDA product code for CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM?

The FDA product code for CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM is FNM.

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Official Source

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

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