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FDA 510(k)

JAYCO HYDROGEN MONITOR

K-Number: K882499 · 1988-06-28

ApplicantEnteron, Inc.
Decision Date1988-06-28
Product CodeNRH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

JAYCO HYDROGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Enteron, Inc.. It received FDA 510(k) clearance on 1988-06-28 under 510(k) number K882499. The device is classified under product code NRH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAYCO HYDROGEN MONITOR?

JAYCO HYDROGEN MONITOR is a medical device that received FDA 510(k) clearance on 1988-06-28. The listed applicant is Enteron, Inc.. The 510(k) number is K882499.

When did JAYCO HYDROGEN MONITOR receive FDA 510(k) clearance?

JAYCO HYDROGEN MONITOR received FDA 510(k) clearance on 1988-06-28, under 510(k) number K882499.

Who is the listed applicant for JAYCO HYDROGEN MONITOR?

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

What is the FDA product code for JAYCO HYDROGEN MONITOR?

The FDA product code for JAYCO HYDROGEN MONITOR is NRH.

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Related Devices (Code: NRH)

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.

K033688MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITYMicro Direct, Inc.K963376MICRO H2Micro Direct, Inc.K874892VITALOGRAPH-EC60 HYDROGEN MONITORVitalograph , Ltd.

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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