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FDA 510(k)

HYDRA METER

K-Number: K974127 · 1997-12-19

ApplicantAutomata Instrumentation, Inc.
Decision Date1997-12-19
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HYDRA METER is the device name listed in this FDA 510(k) record. The listed applicant is Automata Instrumentation, Inc.. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K974127. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRA METER?

HYDRA METER is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Automata Instrumentation, Inc.. The 510(k) number is K974127.

When did HYDRA METER receive FDA 510(k) clearance?

HYDRA METER received FDA 510(k) clearance on 1997-12-19, under 510(k) number K974127.

Who is the listed applicant for HYDRA METER?

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

What is the FDA product code for HYDRA METER?

The FDA product code for HYDRA METER is FIP.

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Other records listing Automata Instrumentation, 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.

K992431NEO-2 METERK981294ODYSSEY INSTRUMENTATION SYSTEM

Related Devices (Code: FIP)

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.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, 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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