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FDA 510(k)

NEO-STAT DIALYSATE METER

K-Number: K920810 · 1993-01-15

ApplicantAutomata Medical Instrumentation, Inc.
Decision Date1993-01-15
Product CodeFIZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEO-STAT DIALYSATE METER is the device name listed in this FDA 510(k) record. The listed applicant is Automata Medical Instrumentation, Inc.. It received FDA 510(k) clearance on 1993-01-15 under 510(k) number K920810. The device is classified under product code FIZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-STAT DIALYSATE METER?

NEO-STAT DIALYSATE METER is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Automata Medical Instrumentation, Inc.. The 510(k) number is K920810.

When did NEO-STAT DIALYSATE METER receive FDA 510(k) clearance?

NEO-STAT DIALYSATE METER received FDA 510(k) clearance on 1993-01-15, under 510(k) number K920810.

Who is the listed applicant for NEO-STAT DIALYSATE METER?

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

What is the FDA product code for NEO-STAT DIALYSATE METER?

The FDA product code for NEO-STAT DIALYSATE METER is FIZ.

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Other records listing Automata Medical 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.

K955298PHOENIX DIALYSATE METER

Related Devices (Code: FIZ)

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.

K201765SmartHDM-510 SystemMesa Laboratories, Inc.K05081290XL INSTRUMENTATION SYSTEMMesa Laboratories, Inc.K020908HDM97Ibp Instruments GmbHK020909HDM99Ibp Instruments GmbHK992431NEO-2 METERAutomata Instrumentation, Inc.K981294ODYSSEY INSTRUMENTATION SYSTEMAutomata Instrumentation, Inc.

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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